Colorectal Neoplasms
Conditions
Brief summary
Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure
Detailed description
Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.
Interventions
DEVICEColonoscopy with EndoCuff™
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
DEVICEFUSE® Colonoscopy
colonoscopy performed with the FUSE® (full spectrum endoscopy) system
DEVICEColonoscopy with EndoRings™
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
DEVICEStandard Colonoscopy
Current standard of care colonoscopy
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Screening or Surveillance Colonoscopy
Exclusion criteria
* Personal history of Colorectal cancer or Inflammatory bowel disease * Surgical resection of the colon or known colonic stricture * Personal or family history of Polyposis syndromes or Lynch syndrome * Referral for incomplete colonoscopy or known therapeutic polyp clearance * Severe diverticular disease * Referral for a positive hemoccult test in the past 6 months * Known coagulopathy * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adenomas Per Colonoscopy | During Procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Detected Adenoma | During Procedure | — |
| Percentage of Participants With Detected Adenoma | During Procedure | — |
| Sessile Serrated Polyps Per Colonoscopy | During Procedure | — |
| Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure | — |
| Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure | — |
| Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure | — |
| Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure | — |
| Percentage of Participants With Detected Sessile Serrated Polyp | During Procedure | — |
| Number of Participants With a Detected Polyp | During Procedure | — |
| Percentage of Participants With a Detected Polyp | During Procedure | — |
| Cecal Insertion Time | During Procedure | — |
| Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | During Procedure | — |
| Inspection Time | During Procedure | — |
| Number of Participants With Detected Sessile Serrated Polyp | During Procedure | Number of patients with 1 or more sessile serrated polyps |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Colonoscopy A standard colonoscope will be used to complete the procedure
Standard Colonoscopy: Current standard of care colonoscopy | 295 |
| Colonoscopy With EndoCuff™ An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope | 299 |
| Colonoscopy With EndoRings™ An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope | 295 |
| FUSE® Colonoscopy A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system | 299 |
| Total | 1,188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Cecum not intubated | 1 | 0 | 0 | 0 |
| Overall Study | Inadequate Bowel Prep | 17 | 16 | 18 | 14 |
| Overall Study | Polyposis identified during procedure | 1 | 1 | 0 | 1 |
| Overall Study | Recognized ineligible post-randomization | 1 | 0 | 2 | 1 |
| Overall Study | Ulcerative Colitis identified | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Colonoscopy With EndoCuff™ | Standard Colonoscopy | Total | FUSE® Colonoscopy | Colonoscopy With EndoRings™ |
|---|---|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 8.2 | 62.6 years STANDARD_DEVIATION 8.3 | 62.6 years STANDARD_DEVIATION 8.3 | 62.3 years STANDARD_DEVIATION 8.7 | 62.3 years STANDARD_DEVIATION 7.9 |
| Indication Diagnostic | 23 Participants | 16 Participants | 75 Participants | 16 Participants | 20 Participants |
| Indication Screening | 126 Participants | 127 Participants | 504 Participants | 128 Participants | 123 Participants |
| Indication Surveillance | 150 Participants | 151 Participants | 607 Participants | 154 Participants | 152 Participants |
| Indication Unknown | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 12 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants | 13 Participants | 61 Participants | 20 Participants | 13 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 6 Participants | 5 Participants | 20 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 276 Participants | 272 Participants | 1093 Participants | 269 Participants | 276 Participants |
| Sex: Female, Male Female | 141 Participants | 139 Participants | 582 Participants | 146 Participants | 156 Participants |
| Sex: Female, Male Male | 158 Participants | 156 Participants | 606 Participants | 153 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 295 | 0 / 299 | 0 / 295 | 0 / 299 |
| other Total, other adverse events | 0 / 295 | 0 / 299 | 0 / 295 | 0 / 299 |
| serious Total, serious adverse events | 0 / 295 | 0 / 299 | 0 / 295 | 0 / 299 |
Outcome results
Primary
Adenomas Per Colonoscopy
Time frame: During Procedure
Population: The number of adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Colonoscopy | Adenomas Per Colonoscopy | All Sites | 1.53 Adenomas per Colonoscopy | Standard Deviation 2.33 |
| Standard Colonoscopy | Adenomas Per Colonoscopy | Indianapolis | 1.89 Adenomas per Colonoscopy | Standard Deviation 2.69 |
| Standard Colonoscopy | Adenomas Per Colonoscopy | Milan | 0.83 Adenomas per Colonoscopy | Standard Deviation 1.18 |
| Standard Colonoscopy | Adenomas Per Colonoscopy | New York | 0.92 Adenomas per Colonoscopy | Standard Deviation 1.15 |
| Colonoscopy With EndoCuff™ | Adenomas Per Colonoscopy | Indianapolis | 2.17 Adenomas per Colonoscopy | Standard Deviation 2.88 |
| Colonoscopy With EndoCuff™ | Adenomas Per Colonoscopy | Milan | 0.80 Adenomas per Colonoscopy | Standard Deviation 1.25 |
| Colonoscopy With EndoCuff™ | Adenomas Per Colonoscopy | New York | 2.00 Adenomas per Colonoscopy | Standard Deviation 2.34 |
| Colonoscopy With EndoCuff™ | Adenomas Per Colonoscopy | All Sites | 1.82 Adenomas per Colonoscopy | Standard Deviation 2.58 |
| Colonoscopy With EndoRings™ | Adenomas Per Colonoscopy | Milan | 0.72 Adenomas per Colonoscopy | Standard Deviation 1.17 |
| Colonoscopy With EndoRings™ | Adenomas Per Colonoscopy | Indianapolis | 1.97 Adenomas per Colonoscopy | Standard Deviation 2.77 |
| Colonoscopy With EndoRings™ | Adenomas Per Colonoscopy | New York | 0.75 Adenomas per Colonoscopy | Standard Deviation 0.94 |
| Colonoscopy With EndoRings™ | Adenomas Per Colonoscopy | All Sites | 1.55 Adenomas per Colonoscopy | Standard Deviation 2.42 |
| FUSE® Colonoscopy | Adenomas Per Colonoscopy | New York | 0.80 Adenomas per Colonoscopy | Standard Deviation 1.32 |
| FUSE® Colonoscopy | Adenomas Per Colonoscopy | Indianapolis | 1.59 Adenomas per Colonoscopy | Standard Deviation 2.18 |
| FUSE® Colonoscopy | Adenomas Per Colonoscopy | All Sites | 1.30 Adenomas per Colonoscopy | Standard Deviation 1.96 |
| FUSE® Colonoscopy | Adenomas Per Colonoscopy | Milan | 0.68 Adenomas per Colonoscopy | Standard Deviation 1.19 |
Secondary
Cecal Insertion Time
Time frame: During Procedure
Population: The mean insertion time was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Colonoscopy | Cecal Insertion Time | All Sites | 422 Seconds | Standard Deviation 319 |
| Standard Colonoscopy | Cecal Insertion Time | Indianapolis | 366 Seconds | Standard Deviation 243 |
| Standard Colonoscopy | Cecal Insertion Time | Milan | 642 Seconds | Standard Deviation 405 |
| Standard Colonoscopy | Cecal Insertion Time | New York | 170 Seconds | Standard Deviation 62 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Time | Indianapolis | 320 Seconds | Standard Deviation 179 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Time | Milan | 503 Seconds | Standard Deviation 254 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Time | New York | 193 Seconds | Standard Deviation 93 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Time | All Sites | 354 Seconds | Standard Deviation 216 |
| Colonoscopy With EndoRings™ | Cecal Insertion Time | Milan | 581 Seconds | Standard Deviation 356 |
| Colonoscopy With EndoRings™ | Cecal Insertion Time | Indianapolis | 352 Seconds | Standard Deviation 191 |
| Colonoscopy With EndoRings™ | Cecal Insertion Time | New York | 251 Seconds | Standard Deviation 110 |
| Colonoscopy With EndoRings™ | Cecal Insertion Time | All Sites | 403 Seconds | Standard Deviation 263 |
| FUSE® Colonoscopy | Cecal Insertion Time | New York | 242 Seconds | Standard Deviation 80 |
| FUSE® Colonoscopy | Cecal Insertion Time | Indianapolis | 395 Seconds | Standard Deviation 225 |
| FUSE® Colonoscopy | Cecal Insertion Time | All Sites | 468 Seconds | Standard Deviation 311 |
| FUSE® Colonoscopy | Cecal Insertion Time | Milan | 731 Seconds | Standard Deviation 385 |
Secondary
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
Time frame: During Procedure
Population: Gastroenterology fellows were allowed to assist in inserting the scope, but times included in this analysis were from insertions done completely by the physician. This is why the overall number analyzed differs from the number analyzed in other outcome measure as well as why the numbers differ depending on site and randomization arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | All Sites | 320 Seconds | Standard Deviation 256 |
| Standard Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Indianapolis | 283 Seconds | Standard Deviation 185 |
| Standard Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Milan | 556 Seconds | Standard Deviation 378 |
| Standard Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | New York | 170 Seconds | Standard Deviation 62 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Indianapolis | 239 Seconds | Standard Deviation 127 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Milan | 438 Seconds | Standard Deviation 269 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | New York | 193 Seconds | Standard Deviation 93 |
| Colonoscopy With EndoCuff™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | All Sites | 265 Seconds | Standard Deviation 173 |
| Colonoscopy With EndoRings™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Milan | 588 Seconds | Standard Deviation 345 |
| Colonoscopy With EndoRings™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Indianapolis | 277 Seconds | Standard Deviation 127 |
| Colonoscopy With EndoRings™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | New York | 251 Seconds | Standard Deviation 110 |
| Colonoscopy With EndoRings™ | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | All Sites | 331 Seconds | Standard Deviation 222 |
| FUSE® Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | New York | 242 Seconds | Standard Deviation 80 |
| FUSE® Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Indianapolis | 340 Seconds | Standard Deviation 169 |
| FUSE® Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | All Sites | 380 Seconds | Standard Deviation 252 |
| FUSE® Colonoscopy | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Milan | 718 Seconds | Standard Deviation 401 |
Secondary
Inspection Time
Time frame: During Procedure
Population: The mean inspection time of all three sites overall was calculated as well as the mean inspection time for each individual site. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Colonoscopy | Inspection Time | Indianapolis | 418 Seconds | Standard Deviation 91 |
| Standard Colonoscopy | Inspection Time | Milan | 501 Seconds | Standard Deviation 109 |
| Standard Colonoscopy | Inspection Time | New York | 467 Seconds | Standard Deviation 95 |
| Standard Colonoscopy | Inspection Time | All Sites | 444 Seconds | Standard Deviation 103 |
| Colonoscopy With EndoCuff™ | Inspection Time | All Sites | 419 Seconds | Standard Deviation 95 |
| Colonoscopy With EndoCuff™ | Inspection Time | Indianapolis | 392 Seconds | Standard Deviation 89 |
| Colonoscopy With EndoCuff™ | Inspection Time | Milan | 492 Seconds | Standard Deviation 78 |
| Colonoscopy With EndoCuff™ | Inspection Time | New York | 414 Seconds | Standard Deviation 84 |
| Colonoscopy With EndoRings™ | Inspection Time | All Sites | 417 Seconds | Standard Deviation 147 |
| Colonoscopy With EndoRings™ | Inspection Time | Milan | 484 Seconds | Standard Deviation 92 |
| Colonoscopy With EndoRings™ | Inspection Time | Indianapolis | 388 Seconds | Standard Deviation 160 |
| Colonoscopy With EndoRings™ | Inspection Time | New York | 438 Seconds | Standard Deviation 96 |
| FUSE® Colonoscopy | Inspection Time | Indianapolis | 378 Seconds | Standard Deviation 83 |
| FUSE® Colonoscopy | Inspection Time | All Sites | 421 Seconds | Standard Deviation 112 |
| FUSE® Colonoscopy | Inspection Time | Milan | 522 Seconds | Standard Deviation 120 |
| FUSE® Colonoscopy | Inspection Time | New York | 454 Seconds | Standard Deviation 81 |
Secondary
Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 205 Adenomas |
| Standard Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 160 Adenomas |
| Standard Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 28 Adenomas |
| Standard Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 17 Adenomas |
| Colonoscopy With EndoCuff™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 199 Adenomas |
| Colonoscopy With EndoCuff™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 37 Adenomas |
| Colonoscopy With EndoCuff™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 17 Adenomas |
| Colonoscopy With EndoCuff™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 253 Adenomas |
| Colonoscopy With EndoRings™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 31 Adenomas |
| Colonoscopy With EndoRings™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 162 Adenomas |
| Colonoscopy With EndoRings™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 20 Adenomas |
| Colonoscopy With EndoRings™ | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 213 Adenomas |
| FUSE® Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 14 Adenomas |
| FUSE® Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 145 Adenomas |
| FUSE® Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 194 Adenomas |
| FUSE® Colonoscopy | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 35 Adenomas |
Secondary
Number of Participants With a Detected Polyp
Time frame: During Procedure
Population: The number of participants with a detected polyp was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Colonoscopy | Number of Participants With a Detected Polyp | All Sites | 226 Participants |
| Standard Colonoscopy | Number of Participants With a Detected Polyp | Indianapolis | 162 Participants |
| Standard Colonoscopy | Number of Participants With a Detected Polyp | Milan | 46 Participants |
| Standard Colonoscopy | Number of Participants With a Detected Polyp | New York | 18 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With a Detected Polyp | Indianapolis | 175 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With a Detected Polyp | Milan | 50 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With a Detected Polyp | New York | 22 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With a Detected Polyp | All Sites | 247 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With a Detected Polyp | Milan | 42 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With a Detected Polyp | Indianapolis | 171 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With a Detected Polyp | New York | 18 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With a Detected Polyp | All Sites | 231 Participants |
| FUSE® Colonoscopy | Number of Participants With a Detected Polyp | New York | 19 Participants |
| FUSE® Colonoscopy | Number of Participants With a Detected Polyp | Indianapolis | 155 Participants |
| FUSE® Colonoscopy | Number of Participants With a Detected Polyp | All Sites | 212 Participants |
| FUSE® Colonoscopy | Number of Participants With a Detected Polyp | Milan | 38 Participants |
Secondary
Number of Participants With Detected Adenoma
Time frame: During Procedure
Population: The number of participants with detected adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Colonoscopy | Number of Participants With Detected Adenoma | All Sites | 166 Participants |
| Standard Colonoscopy | Number of Participants With Detected Adenoma | Indianapolis | 117 Participants |
| Standard Colonoscopy | Number of Participants With Detected Adenoma | Milan | 37 Participants |
| Standard Colonoscopy | Number of Participants With Detected Adenoma | New York | 12 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Adenoma | Indianapolis | 137 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Adenoma | Milan | 35 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Adenoma | New York | 19 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Adenoma | All Sites | 191 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Adenoma | Milan | 29 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Adenoma | Indianapolis | 127 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Adenoma | New York | 11 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Adenoma | All Sites | 167 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Adenoma | New York | 11 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Adenoma | Indianapolis | 115 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Adenoma | All Sites | 154 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Adenoma | Milan | 28 Participants |
Secondary
Number of Participants With Detected Sessile Serrated Polyp
Number of patients with 1 or more sessile serrated polyps
Time frame: During Procedure
Population: The number of participants with detected sessile serrated polyps was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | All Sites | 36 Participants |
| Standard Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | Indianapolis | 33 Participants |
| Standard Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | Milan | 2 Participants |
| Standard Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | New York | 1 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Sessile Serrated Polyp | Indianapolis | 29 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Sessile Serrated Polyp | Milan | 2 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Sessile Serrated Polyp | New York | 2 Participants |
| Colonoscopy With EndoCuff™ | Number of Participants With Detected Sessile Serrated Polyp | All Sites | 33 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Sessile Serrated Polyp | Milan | 1 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Sessile Serrated Polyp | Indianapolis | 31 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Sessile Serrated Polyp | New York | 1 Participants |
| Colonoscopy With EndoRings™ | Number of Participants With Detected Sessile Serrated Polyp | All Sites | 33 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | New York | 1 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | Indianapolis | 27 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | All Sites | 30 Participants |
| FUSE® Colonoscopy | Number of Participants With Detected Sessile Serrated Polyp | Milan | 2 Participants |
Secondary
Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 20 Sessile Serrated Polyps |
| Standard Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 9 Sessile Serrated Polyps |
| Standard Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 6 Sessile Serrated Polyps |
| Standard Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 5 Sessile Serrated Polyps |
| Colonoscopy With EndoCuff™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 11 Sessile Serrated Polyps |
| Colonoscopy With EndoCuff™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 10 Sessile Serrated Polyps |
| Colonoscopy With EndoCuff™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 11 Sessile Serrated Polyps |
| Colonoscopy With EndoCuff™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 32 Sessile Serrated Polyps |
| Colonoscopy With EndoRings™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 8 Sessile Serrated Polyps |
| Colonoscopy With EndoRings™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 8 Sessile Serrated Polyps |
| Colonoscopy With EndoRings™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 13 Sessile Serrated Polyps |
| Colonoscopy With EndoRings™ | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 29 Sessile Serrated Polyps |
| FUSE® Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 12 Sessile Serrated Polyps |
| FUSE® Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 9 Sessile Serrated Polyps |
| FUSE® Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | All | 25 Sessile Serrated Polyps |
| FUSE® Colonoscopy | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 4 Sessile Serrated Polyps |
Secondary
Percentage of Participants With a Detected Polyp
Time frame: During Procedure
Population: The number of participants analyzed for each site differed because the percentage of patients with a polyp was calculated for each site specifically. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Colonoscopy | Percentage of Participants With a Detected Polyp | All Sites | 77 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With a Detected Polyp | Indianapolis | 84 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With a Detected Polyp | Milan | 59 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With a Detected Polyp | New York | 72 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With a Detected Polyp | Indianapolis | 89 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With a Detected Polyp | Milan | 68 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With a Detected Polyp | New York | 79 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With a Detected Polyp | All Sites | 83 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With a Detected Polyp | Milan | 56 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With a Detected Polyp | Indianapolis | 87 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With a Detected Polyp | New York | 75 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With a Detected Polyp | All Sites | 78 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With a Detected Polyp | New York | 76 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With a Detected Polyp | Indianapolis | 78 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With a Detected Polyp | All Sites | 71 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With a Detected Polyp | Milan | 51 Percentage of Participants |
Secondary
Percentage of Participants With Detected Adenoma
Time frame: During Procedure
Population: The number of participants analyzed differed because the calculation was done for all three sites overall and then broken down into each specific site. Thus, only patients randomized to the treatment arm at that site were included in the specific site calculations instead of including the total number of patients randomized to that treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Colonoscopy | Percentage of Participants With Detected Adenoma | All Sites | 56 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With Detected Adenoma | Indianapolis | 61 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With Detected Adenoma | Milan | 47 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With Detected Adenoma | New York | 48 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Adenoma | Indianapolis | 70 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Adenoma | Milan | 47 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Adenoma | New York | 68 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Adenoma | All Sites | 64 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Adenoma | Milan | 39 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Adenoma | Indianapolis | 65 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Adenoma | New York | 46 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Adenoma | All Sites | 57 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Adenoma | New York | 44 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Adenoma | Indianapolis | 58 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Adenoma | All Sites | 52 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Adenoma | Milan | 37 Percentage of Participants |
Secondary
Percentage of Participants With Detected Sessile Serrated Polyp
Time frame: During Procedure
Population: The number of participants analyzed for each site differed because the percentage of patients with a sessile serrated polyp was calculated specifically for the site. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | All Sites | 12 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | Indianapolis | 17 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | Milan | 3 Percentage of Participants |
| Standard Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | New York | 4 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Sessile Serrated Polyp | Indianapolis | 15 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Sessile Serrated Polyp | Milan | 3 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Sessile Serrated Polyp | New York | 7 Percentage of Participants |
| Colonoscopy With EndoCuff™ | Percentage of Participants With Detected Sessile Serrated Polyp | All Sites | 11 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Sessile Serrated Polyp | Milan | 1 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Sessile Serrated Polyp | Indianapolis | 16 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Sessile Serrated Polyp | New York | 4 Percentage of Participants |
| Colonoscopy With EndoRings™ | Percentage of Participants With Detected Sessile Serrated Polyp | All Sites | 11 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | New York | 4 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | Indianapolis | 14 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | All Sites | 10 Percentage of Participants |
| FUSE® Colonoscopy | Percentage of Participants With Detected Sessile Serrated Polyp | Milan | 3 Percentage of Participants |
Secondary
Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Colonoscopy | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 78 Percentage of Adenomas |
| Standard Colonoscopy | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 7 Percentage of Adenomas |
| Standard Colonoscopy | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 14 Percentage of Adenomas |
| Colonoscopy With EndoCuff™ | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 79 Percentage of Adenomas |
| Colonoscopy With EndoCuff™ | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 7 Percentage of Adenomas |
| Colonoscopy With EndoCuff™ | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 15 Percentage of Adenomas |
| Colonoscopy With EndoRings™ | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 15 Percentage of Adenomas |
| Colonoscopy With EndoRings™ | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 76 Percentage of Adenomas |
| Colonoscopy With EndoRings™ | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 9 Percentage of Adenomas |
| FUSE® Colonoscopy | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 75 Percentage of Adenomas |
| FUSE® Colonoscopy | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 7 Percentage of Adenomas |
| FUSE® Colonoscopy | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 18 Percentage of Adenomas |
Secondary
Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
Time frame: During Procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Colonoscopy | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 45 Percentage of Sessile Serrated Polyps |
| Standard Colonoscopy | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 25 Percentage of Sessile Serrated Polyps |
| Standard Colonoscopy | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 30 Percentage of Sessile Serrated Polyps |
| Colonoscopy With EndoCuff™ | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 34 Percentage of Sessile Serrated Polyps |
| Colonoscopy With EndoCuff™ | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 34 Percentage of Sessile Serrated Polyps |
| Colonoscopy With EndoCuff™ | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 31 Percentage of Sessile Serrated Polyps |
| Colonoscopy With EndoRings™ | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 28 Percentage of Sessile Serrated Polyps |
| Colonoscopy With EndoRings™ | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 28 Percentage of Sessile Serrated Polyps |
| Colonoscopy With EndoRings™ | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 45 Percentage of Sessile Serrated Polyps |
| FUSE® Colonoscopy | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 1-5mm | 36 Percentage of Sessile Serrated Polyps |
| FUSE® Colonoscopy | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | greater than or equal to 10mm | 48 Percentage of Sessile Serrated Polyps |
| FUSE® Colonoscopy | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | 6-9mm | 16 Percentage of Sessile Serrated Polyps |
Secondary
Sessile Serrated Polyps Per Colonoscopy
Time frame: During Procedure
Population: The number of sessile serrated polyps per colonoscopy was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | All Sites | 0.17 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.54 |
| Standard Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | Indianapolis | 0.24 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.64 |
| Standard Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | Milan | 0.03 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.16 |
| Standard Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | New York | 0.04 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.2 |
| Colonoscopy With EndoCuff™ | Sessile Serrated Polyps Per Colonoscopy | Indianapolis | 0.23 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.63 |
| Colonoscopy With EndoCuff™ | Sessile Serrated Polyps Per Colonoscopy | Milan | 0.04 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.26 |
| Colonoscopy With EndoCuff™ | Sessile Serrated Polyps Per Colonoscopy | New York | 0.07 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.26 |
| Colonoscopy With EndoCuff™ | Sessile Serrated Polyps Per Colonoscopy | All Sites | 0.17 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.54 |
| Colonoscopy With EndoRings™ | Sessile Serrated Polyps Per Colonoscopy | Milan | 0.01 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.12 |
| Colonoscopy With EndoRings™ | Sessile Serrated Polyps Per Colonoscopy | Indianapolis | 0.29 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.98 |
| Colonoscopy With EndoRings™ | Sessile Serrated Polyps Per Colonoscopy | New York | 0.04 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.2 |
| Colonoscopy With EndoRings™ | Sessile Serrated Polyps Per Colonoscopy | All Sites | 0.20 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.81 |
| FUSE® Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | New York | 0.04 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.2 |
| FUSE® Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | Indianapolis | 0.25 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.89 |
| FUSE® Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | All Sites | 0.18 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.74 |
| FUSE® Colonoscopy | Sessile Serrated Polyps Per Colonoscopy | Milan | 0.03 Sessile Serrated Polyps per colonoscopy | Standard Deviation 0.16 |