Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Study Overview
=================
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.

Official Title
-----------------
Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

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 |
| --- | --- |
| Experimental: Endocuff Vision Arm<br>Colonoscopy with Endocuff Vision device attached to the distal end of the scope. | Device: Endocuff Vision device<br>* Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.<br>|
| Experimental: AmplifEYE Arm<br>Colonoscopy with AmplifEYE device attached to the distal end of the scope. | Device: AmplifEYE device<br>* Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During colonoscopy procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During colonoscopy procedure | 
| 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. | During Colonoscopy procedure | 
| 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. | during insertion portion of colonoscopy | 
| Polyps Per Colonoscopy (PPC) | Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy. | During colonoscopy procedure | 
| 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. | During colonoscopy procedure | 
| 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. | During Colonoscopy procedure | 
| 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. | During colonoscopy procedure | 

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