Colon Cancer
Conditions
Keywords
polyp/adenoma miss rate, colonoscopy add-on device, enhanced screening
Brief summary
To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy. To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.
Detailed description
Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two back-to-back procedures. Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy. Subjects in Group B (control group) will undergo an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy. Results from the two groups will be analyzed and compared, with primary outcome measures being adenoma miss rate and polyp miss rate. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results. Subjects will be followed through a 24 hour and a 7-days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance. Multi-center study with up to 126 patients. Up to 126 treated patients (2 groups of 57 patients +6 drop-out patients) will be enrolled into the study.
Interventions
DEVICETandem Colonoscopy
Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order.
Sponsors
EndoAid
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject between the ages of 40 and 75 * The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; * Written informed consent must be available before enrollment in the trial
Exclusion criteria
* Patients with a history of colonic resection; * Patients with known (or newly diagnosed) inflammatory bowel disease; * Patients with a personal history of polyposis syndrome; * Patients with suspected chronic stricture potentially precluding complete colonoscopy; * Patients with diverticulitis or toxic megacolon; * Patients with a history of radiation therapy to abdomen or pelvis; * Patients with a hemorrhagic diathesis * Patients with acute lower GI bleeding * Pregnant women and women with childbearing potential without adequate contraception * Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma and Polyp Miss Rate | 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total. | Group A- we measured the Adenoma&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings). Group B- we measured the Adenoma&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard). Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group\]\*100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured | During the procedure | The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured |
| Sedation | During the procedure | Sedation dosage |
| Total Number of Therapeutic Interventions Performed | Interventions during procedure | Ability to perform therapeutic interventions, such as biopsies, polypectomies, APC etc. during the Standard Colonoscopy and during the EndoRings Colonoscopy. The number of interventions was not compared, this was just a safety outcome meant to prove there was no difficulty in performing interventions in both arms. |
| Colon Area Screened | During the procedure | Subjective evaluation of the additional area screened by the physician. |
| Patient Satisfaction | 24 hours post procedure | Follow up phone call was done 24 hours post procedure. Patients were asked the following : On a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your colonoscopy experience? 0 1 2 3 4 5 6 7 8 9 10 |
| Scope Centering Ability | During the procedure | Ability to center the scope inside the gastrointestinal tract. |
Countries
Israel, Netherlands, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy. | 59 |
| Group B Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device) . | 57 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 5 | 5 |
Baseline characteristics
| Characteristic | Group B | Group A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 19 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Age, Continuous | 57.9 years STANDARD_DEVIATION 9.1 | 59.6 years STANDARD_DEVIATION 9.3 | 58.7 years STANDARD_DEVIATION 9.2 |
| Gender Female | 16 Participants | 29 Participants | 45 Participants |
| Gender Male | 41 Participants | 30 Participants | 71 Participants |
| Region of Enrollment Israel | 18 participants | 20 participants | 38 participants |
| Region of Enrollment Netherlands | 36 participants | 34 participants | 70 participants |
| Region of Enrollment United States | 3 participants | 5 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 59 | 0 / 57 |
| serious Total, serious adverse events | 0 / 59 | 0 / 57 |
Outcome results
Primary
Adenoma and Polyp Miss Rate
Group A- we measured the Adenoma&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings). Group B- we measured the Adenoma&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard). Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group\]\*100
Time frame: 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Adenoma and Polyp Miss Rate | Adenoma Miss Rate | 48.3 percentage of :Adenomas/Polyp missed |
| Group A | Adenoma and Polyp Miss Rate | Polyp Miss Rate | 52.8 percentage of :Adenomas/Polyp missed |
| Group B | Adenoma and Polyp Miss Rate | Adenoma Miss Rate | 10.4 percentage of :Adenomas/Polyp missed |
| Group B | Adenoma and Polyp Miss Rate | Polyp Miss Rate | 9.1 percentage of :Adenomas/Polyp missed |
Secondary
Colon Area Screened
Subjective evaluation of the additional area screened by the physician.
Time frame: During the procedure
Population: Evaluation of the additional area screened by the physician was not collected from any participant during the study
Secondary
Patient Satisfaction
Follow up phone call was done 24 hours post procedure. Patients were asked the following : On a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your colonoscopy experience? 0 1 2 3 4 5 6 7 8 9 10
Time frame: 24 hours post procedure
Population: Data was not analyzed since the patients satisfactory score was general estimation which could not be associated with either the standard colonoscopy or the EndoRings colonoscopy, therefore the intended endpoint failed.
Secondary
Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured
The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured
Time frame: During the procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured | Withdrawal time | 7.4 minutes | Standard Deviation 1.9 |
| Group A | Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured | Total procedure time | 21.6 minutes | Standard Deviation 8.9 |
| Group A | Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured | Time to cecum | 9.3 minutes | Standard Deviation 7.3 |
| Group B | Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured | Withdrawal time | 7.2 minutes | Standard Deviation 2.2 |
| Group B | Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured | Total procedure time | 18.5 minutes | Standard Deviation 8.2 |
| Group B | Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured | Time to cecum | 8.4 minutes | Standard Deviation 5.6 |
Secondary
Scope Centering Ability
Ability to center the scope inside the gastrointestinal tract.
Time frame: During the procedure
Population: Centering ability was not collected from any procedure during the study
Secondary
Sedation
Sedation dosage
Time frame: During the procedure
Population: Sedation dosage was not collected from any participant during the study
Secondary
Total Number of Therapeutic Interventions Performed
Ability to perform therapeutic interventions, such as biopsies, polypectomies, APC etc. during the Standard Colonoscopy and during the EndoRings Colonoscopy. The number of interventions was not compared, this was just a safety outcome meant to prove there was no difficulty in performing interventions in both arms.
Time frame: Interventions during procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Total Number of Therapeutic Interventions Performed | 106 Total Interventions performed |
| Group B | Total Number of Therapeutic Interventions Performed | 121 Total Interventions performed |