Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study

Conditions
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Colon Cancer

Intervention / Treatment
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* Device: Tandem Colonoscopy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy. | Device: Tandem Colonoscopy<br>* 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.<br>* Other names: Colon screening;|
| Other: Group B<br>Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures: an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy. | Device: Tandem Colonoscopy<br>* 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.<br>* Other names: Colon screening;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Interventions during procedure | 
| 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 | During the procedure | 
| Sedation | Sedation dosage | During the procedure | 
| Scope Centering Ability | Ability to center the scope inside the gastrointestinal tract. | During the procedure | 
| Colon Area Screened | Subjective evaluation of the additional area screened by the physician. | During the procedure | 
| 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 | 24 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyp/adenoma miss rate, colonoscopy add-on device, enhanced screening