Clinical trial NCT02345889: A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
Official title: A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 1262
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenomas Per Colonoscopy
timeFrame: During Procedure
Secondary outcomes:
measure: Number of Participants With Detected Adenoma
timeFrame: During Procedure
measure: Percentage of Participants With Detected Adenoma
timeFrame: During Procedure
measure: Sessile Serrated Polyps Per Colonoscopy
timeFrame: During Procedure
measure: Number of Participants With Detected Sessile Serrated Polyp
timeFrame: During Procedure
measure: Percentage of Participants With Detected Sessile Serrated Polyp
timeFrame: During Procedure
measure: Number of Participants With a Detected Polyp
timeFrame: During Procedure
measure: Percentage of Participants With a Detected Polyp
timeFrame: During Procedure
measure: Cecal Insertion Time
timeFrame: During Procedure
measure: Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion
timeFrame: During Procedure
measure: Inspection Time
timeFrame: During Procedure
measure: Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
timeFrame: During Procedure
measure: Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
timeFrame: During Procedure
measure: Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
timeFrame: During Procedure
measure: Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.
timeFrame: During Procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Douglas Rex, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rex DK, Repici A, Gross SA, Hassan C, Ponugoti PL, Garcia JR, Broadley HM, Thygesen JC, Sullivan AW, Tippins WW, Main SA, Eckert GJ, Vemulapalli KC. High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial. Gastrointest Endosc. 2018 Aug;88(2):335-344.e2. doi: 10.1016/j.gie.2018.02.043. Epub 2018 Mar 9.