A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Study Overview
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Brief Summary
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Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure

Detailed Description
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Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

Official Title
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A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Device: Colonoscopy with EndoCuff™
* Device: FUSE® Colonoscopy
* Device: Colonoscopy with EndoRings™
* Device: Standard Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening or Surveillance Colonoscopy Exclusion Criteria: Personal history of Colorectal cancer or Inflammatory bowel disease Surgical resection of the colon or known colonic stricture Personal or family history of Polyposis syndromes or Lynch syndrome Referral for incomplete colonoscopy or known therapeutic polyp clearance Severe diverticular disease Referral for a positive hemoccult test in the past 6 months Known coagulopathy Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 50 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FUSE® Colonoscopy<br>A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy | Device: FUSE® Colonoscopy<br>* colonoscopy performed with the FUSE® (full spectrum endoscopy) system<br>|
| Active Comparator: Colonoscopy with EndoCuff™<br>An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope | Device: Colonoscopy with EndoCuff™<br>* colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope<br>|
| Active Comparator: Colonoscopy with EndoRings™<br>An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope | Device: Colonoscopy with EndoRings™<br>* colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope<br>|
| Active Comparator: Standard Colonoscopy<br>A standard colonoscope will be used to complete the procedure | Device: Standard Colonoscopy<br>* Current standard of care colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenomas Per Colonoscopy |  | During Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Detected Adenoma |  | During Procedure | 
| Percentage of Participants With Detected Adenoma |  | During Procedure | 
| Sessile Serrated Polyps Per Colonoscopy |  | During Procedure | 
| Number of Participants With Detected Sessile Serrated Polyp | Number of patients with 1 or more sessile serrated polyps | During Procedure | 
| Percentage of Participants With Detected Sessile Serrated Polyp |  | During Procedure | 
| Number of Participants With a Detected Polyp |  | During Procedure | 
| Percentage of Participants With a Detected Polyp |  | During Procedure | 
| Cecal Insertion Time |  | During Procedure | 
| Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion |  | During Procedure | 
| Inspection Time |  | During Procedure | 
| Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |  | During Procedure | 
| Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |  | During Procedure | 
| Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |  | During Procedure | 
| Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. |  | During Procedure |