EndoRings Colonoscopy vs Standard Colonoscopy

Study Overview
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Brief Summary
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The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Detailed Description
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This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Official Title
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A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).

Conditions
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Colorectal Adenoma, Colorectal Polyp, Colon Cancer

Intervention / Treatment
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* Device: EndoRings device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening or Surveillance Colonoscopy Able to provide written informed consent Exclusion Criteria: Known narrow colon or colon stenosis Personal history of Colorectal cancer History of inflammatory bowel disease Familial adenomatous polyposis syndrome (FAP) Hyperplastic polyposis syndrome Referral for incomplete colonoscopy or polyp clearance
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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm (Standard Colonoscopy)<br>Standard colonoscopy with no device attachment. | |
| Experimental: EndoRings Colonoscopy<br>Colonoscopy with EndoRings device attached to the distal end of the scope. | Device: EndoRings device<br>* Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rates | Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings. | During colonoscopy procedure | 
| Number of Adenomas Per Colonoscopy | Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy. | During colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp Detection Rate | Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings. | During colonoscopy procedure | 
| Number of Detections Per Colonoscopy | Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy. | During colonoscopy procedure | 
| Total Number of Detections | Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy. | During colonoscopy procedure | 
| Cecal Intubation Rate | Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy. | During colonoscopy procedure | 
| Time Comparison for Each Method | Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal). | During colonoscopy procedure | 
| Patient Comfort Score | Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome). | After colonoscopy was completed while patient was in recovery area of endoscopy unit | 
| Problems Encountered With Equipment | Occurrences of slippage of EndoRings or of device being removed on insertion. | During colonoscopy procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy