Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Study Overview
=================
Brief Summary
-----------------
This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

Detailed Description
-----------------
For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Official Title
-----------------
Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

Conditions
-----------------
Colorectal Polyp, Colorectal Adenoma, Colon Cancer

Intervention / Treatment
-----------------
* Device: Endocuff Vision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject referred for a screening or surveillance colonoscopy Subject is aged 40 years or older Subject has the ability to provide informed consent Exclusion Criteria: Prior history of colon cancer History of inflammatory bowel disease Prior surgical resection of any part of the colon Use of antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure History of polyposis syndrome or HNPCC Family history of colon cancer in a first-degree relative < 60 years or two first degree relatives with colorectal cancer Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 Colonscopy)<br>Standard colonoscopy with no device attachments | |
| Experimental: Endocuff Vision<br>Colonoscopy with Endocuff Vision attached to distal end of scope | Device: Endocuff Vision<br>* Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch. | During the withdrawal portion of the colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached. | During the insertion portion of the colonoscopy procedure | 
| Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Total procedure time is the time from the initial insertion through the complete withdrawal of the scope | During the colonoscopy procedure | 
| Detection Rates | The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision. | During the colonoscopy procedure | 
| Polyps Per Colonoscopy | Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision. | During the colonoscopy procedure | 
| Boston Bowel Preparation Score | Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist. | During the withdrawal portion of the colonoscopy procedure after cleaning of the colon | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy screening, Colonscopy procedure