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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345889
• Other study ID #: 1412036333
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1262
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• Colonoscopy with EndoCuff™
colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
• FUSE® Colonoscopy
colonoscopy performed with the FUSE® (full spectrum endoscopy) system
• Colonoscopy with EndoRings™
colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
• Standard Colonoscopy
Current standard of care colonoscopy

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

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