Colorectal Adenoma, Colorectal Cancer, Colorectal Polyp
Conditions
Keywords
Colonoscopy
Brief summary
The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.
Detailed description
This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy. It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.
Interventions
DEVICEEndocuff Vision device
Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
DEVICEAmplifEYE device
Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 40 years of age or older * Undergoing colonoscopy for screening, surveillance, or diagnostic purposes * Able to provide written informed consent
Exclusion criteria
* Active Inflammatory Bowel Disease * Prior resection of the colon * Referred for resection of a polyp identified by another physician * Referred for a previous incomplete colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adenomas Detected Per Colonoscopy (APC). | During colonoscopy procedure | Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR)) | During colonoscopy procedure | Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. |
| Complications Encountered During Procedure | During Colonoscopy procedure | Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy. |
| Passage of Device Through Sigmoid Colon | during insertion portion of colonoscopy | Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device. |
| Time Comparison for Each Method | During colonoscopy procedure | Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps. Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps. Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope. |
| Cecal Intubation Rate | During Colonoscopy procedure | Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy. |
| Detection of Serrated Lesions | During colonoscopy procedure | Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. |
| Polyps Per Colonoscopy (PPC) | During colonoscopy procedure | Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AmplifEYE Arm Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure. | 294 |
| Endocuff Vision Arm Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure. | 298 |
| Total | 592 |
Baseline characteristics
| Characteristic | Endocuff Vision Arm | Total | AmplifEYE Arm |
|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 9.7 | 62.7 years STANDARD_DEVIATION 9.9 | 62.1 years STANDARD_DEVIATION 10 |
| Indication for Procedure Diagnostic | 24 Participants | 42 Participants | 18 Participants |
| Indication for Procedure Screening | 113 Participants | 213 Participants | 100 Participants |
| Indication for Procedure Surveillance | 160 Participants | 331 Participants | 171 Participants |
| Race/Ethnicity, Customized Other | 30 Participants | 60 Participants | 30 Participants |
| Race/Ethnicity, Customized White | 268 Participants | 532 Participants | 264 Participants |
| Region of Enrollment United States | 298 participants | 592 participants | 294 participants |
| Sex: Female, Male Female | 170 Participants | 325 Participants | 155 Participants |
| Sex: Female, Male Male | 128 Participants | 267 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 294 | 0 / 298 |
| other Total, other adverse events | 0 / 294 | 0 / 298 |
| serious Total, serious adverse events | 0 / 294 | 0 / 298 |
Outcome results
Primary
Number of Adenomas Detected Per Colonoscopy (APC).
Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AmplifEYE Arm | Number of Adenomas Detected Per Colonoscopy (APC). | 1.63 adenomas | Standard Deviation 2.8 |
| Endocuff Vision Arm | Number of Adenomas Detected Per Colonoscopy (APC). | 1.51 adenomas | Standard Deviation 2.3 |
Secondary
Cecal Intubation Rate
Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.
Time frame: During Colonoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AmplifEYE Arm | Cecal Intubation Rate | 294 Participants |
| Endocuff Vision Arm | Cecal Intubation Rate | 297 Participants |
Secondary
Complications Encountered During Procedure
Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
Time frame: During Colonoscopy procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AmplifEYE Arm | Complications Encountered During Procedure | Mucosal Trauma | 30 Participants |
| AmplifEYE Arm | Complications Encountered During Procedure | GI Bleeding | 0 Participants |
| AmplifEYE Arm | Complications Encountered During Procedure | Perforation | 0 Participants |
| Endocuff Vision Arm | Complications Encountered During Procedure | GI Bleeding | 0 Participants |
| Endocuff Vision Arm | Complications Encountered During Procedure | Mucosal Trauma | 24 Participants |
| Endocuff Vision Arm | Complications Encountered During Procedure | Perforation | 0 Participants |
Secondary
Detection of Serrated Lesions
Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AmplifEYE Arm | Detection of Serrated Lesions | at least one flat polyp detected | 122 Participants |
| AmplifEYE Arm | Detection of Serrated Lesions | at least one sessile serrated polyp detected | 40 Participants |
| Endocuff Vision Arm | Detection of Serrated Lesions | at least one sessile serrated polyp detected | 46 Participants |
| Endocuff Vision Arm | Detection of Serrated Lesions | at least one flat polyp detected | 130 Participants |
Secondary
Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AmplifEYE Arm | Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR)) | at least 1 detected adenoma | 164 Participants |
| AmplifEYE Arm | Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR)) | at least 1 detected polyp | 229 Participants |
| Endocuff Vision Arm | Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR)) | at least 1 detected adenoma | 159 Participants |
| Endocuff Vision Arm | Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR)) | at least 1 detected polyp | 231 Participants |
Secondary
Passage of Device Through Sigmoid Colon
Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
Time frame: during insertion portion of colonoscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AmplifEYE Arm | Passage of Device Through Sigmoid Colon | 17 Participants |
| Endocuff Vision Arm | Passage of Device Through Sigmoid Colon | 15 Participants |
Secondary
Polyps Per Colonoscopy (PPC)
Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Time frame: During colonoscopy procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AmplifEYE Arm | Polyps Per Colonoscopy (PPC) | 2.71 Polyps | Standard Deviation 3.4 |
| Endocuff Vision Arm | Polyps Per Colonoscopy (PPC) | 2.55 Polyps | Standard Deviation 2.9 |
Secondary
Time Comparison for Each Method
Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps. Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps. Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.
Time frame: During colonoscopy procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AmplifEYE Arm | Time Comparison for Each Method | Insertion Time | 5.6 Minutes | Standard Deviation 3.7 |
| AmplifEYE Arm | Time Comparison for Each Method | Overall Withdrawal Time | 14.6 Minutes | Standard Deviation 6.2 |
| AmplifEYE Arm | Time Comparison for Each Method | Inspection Time | 6.8 Minutes | Standard Deviation 2.3 |
| AmplifEYE Arm | Time Comparison for Each Method | Total Procedure Time | 21.1 Minutes | Standard Deviation 7.8 |
| Endocuff Vision Arm | Time Comparison for Each Method | Total Procedure Time | 21.5 Minutes | Standard Deviation 7.6 |
| Endocuff Vision Arm | Time Comparison for Each Method | Insertion Time | 5.7 Minutes | Standard Deviation 4.1 |
| Endocuff Vision Arm | Time Comparison for Each Method | Inspection Time | 6.9 Minutes | Standard Deviation 1.6 |
| Endocuff Vision Arm | Time Comparison for Each Method | Overall Withdrawal Time | 14.9 Minutes | Standard Deviation 6.3 |