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

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Device: Colonoscopy with EndoRings™; Device: Colonoscopy with EndoCuff™; Device: FUSE® Colonoscopy; Device: Standard Colonoscopy

• Registration Number: NCT02345889
• Lead Sponsor: Indiana University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Study Start: 2015-02
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2018-12-31
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-15
• Last Update Submitted: 2019-02-15
• Results First Posted: 2019-03-12
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1262

Inclusion Criteria

• Screening or Surveillance Colonoscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colonoscopy with EndoRings™	Colonoscopy with EndoRings™	An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™	Colonoscopy with EndoCuff™	An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
FUSE® Colonoscopy	FUSE® Colonoscopy	A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy
Standard Colonoscopy	Standard Colonoscopy	A standard colonoscope will be used to complete the procedure

Primary Outcome Measures

Name	Time	Method
Adenomas Per Colonoscopy	During Procedure

Secondary Outcome Measures

Name	Time	Method
Inspection Time	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
Percentage of Participants With Detected Sessile Serrated Polyp	During Procedure
Number of Participants With a Detected Polyp	During Procedure
Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion	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
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
Number of Participants With Detected Adenoma	During Procedure
Percentage of Participants With Detected Adenoma	During Procedure
Sessile Serrated Polyps Per Colonoscopy	During Procedure
Percentage of Participants With a Detected Polyp	During Procedure
Number of Participants With Detected Sessile Serrated Polyp	During Procedure	Number of patients with 1 or more sessile serrated polyps
Cecal Insertion Time	During Procedure

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States