Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE)

NCT03952611 | Completed DMC FDA Device

• 1 other identifier: RND#00978
• Study Type: interventional
• Target: 1,203
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone Design: Multicenter, Prospective, randomized controlled study Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.

  Through the study (1 year)

Secondary Outcomes (7)

• Number of Adenomas per person

  Through the study (1 year)

• detection rates of advanced adenomas

  Through the study (1 year)

• detect rates of serrated polyps

  Through the study (1 year)

• detect rates of right sided adenomas

  Through the study (1 year)

• to determine cecal intubation time

  Through the study (1 year)

Study Arms (3)

High-Definition White-light Colonoscopy

ACTIVE COMPARATOR

Using an instrument called colonoscope which is used to detect colonic polyps

Procedure: Colonoscopy

High-Definition White-light Colonoscopy With Reveal®

ACTIVE COMPARATOR

Using an instrument called cap at end of colonoscope which is used to straighten colon folds

Procedure: Colonoscopy; Device: distal Cap

High-Definition White-light Colonoscopy With Endocuff Vision

ACTIVE COMPARATOR

Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds

Procedure: Colonoscopy; Device: Endocuff

Interventions

Colonoscopy PROCEDURE

Using an instrument called colonoscope which is used to detect colonic polyps

High-Definition White-light Colonoscopy; High-Definition White-light Colonoscopy With Endocuff Vision; High-Definition White-light Colonoscopy With Reveal®

distal Cap DEVICE

Using an instrument called cap at end of colonoscope which is used to straighten colon folds

High-Definition White-light Colonoscopy With Reveal®

Endocuff DEVICE

Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds

High-Definition White-light Colonoscopy With Endocuff Vision

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referral for screening or surveillance colonoscopy
• Ability to provide informed consent

You may not qualify if:

• Prior history of colon cancer
• History of inflammatory bowel disease
• Prior surgical resection of any part of the colon
• Use of anti-platelet agents or anticoagulants that precludes the removal of polyps during the procedure
• History of polyposis syndrome or HNPCC
• Inability to give informed consent
• Family history of colon cancer in a first degree relative \< 60 years or two first degree relatives with colorectal cancer

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead

Study Sites (1)

Kansas City VA Hospital

Kansas City, Missouri, 64128, United States

Location

Related Publications (10)

• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.

  PMID: 22237781 BACKGROUND

• Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. doi: 10.1053/j.gastro.2006.03.012.

  PMID: 16697750 BACKGROUND

• Citarda F, Tomaselli G, Capocaccia R, Barcherini S, Crespi M; Italian Multicentre Study Group. Efficacy in standard clinical practice of colonoscopic polypectomy in reducing colorectal cancer incidence. Gut. 2001 Jun;48(6):812-5. doi: 10.1136/gut.48.6.812.

  PMID: 11358901 BACKGROUND

• van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.

  PMID: 16454841 BACKGROUND

• Heresbach D, Barrioz T, Lapalus MG, Coumaros D, Bauret P, Potier P, Sautereau D, Boustiere C, Grimaud JC, Barthelemy C, See J, Serraj I, D'Halluin PN, Branger B, Ponchon T. Miss rate for colorectal neoplastic polyps: a prospective multicenter study of back-to-back video colonoscopies. Endoscopy. 2008 Apr;40(4):284-90. doi: 10.1055/s-2007-995618.

  PMID: 18389446 BACKGROUND

• Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.

  PMID: 25470133 BACKGROUND

• Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.

  PMID: 21997547 BACKGROUND

• Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166.

  PMID: 24921209 BACKGROUND

• Desai M, Rex DK, Bohm ME, Davitkov P, DeWitt JM, Fischer M, Faulx G, Heath R, Imler TD, James-Stevenson TN, Kahi CJ, Kessler WR, Kohli DR, McHenry L, Rai T, Rogers NA, Sagi SV, Sathyamurthy A, Vennalaganti P, Sundaram S, Patel H, Higbee A, Kennedy K, Lahr R, Stojadinovikj G, Campbell C, Dasari C, Parasa S, Faulx A, Sharma P. Impact of withdrawal time on adenoma detection rate: results from a prospective multicenter trial. Gastrointest Endosc. 2023 Mar;97(3):537-543.e2. doi: 10.1016/j.gie.2022.09.031. Epub 2022 Oct 10.

  PMID: 36228700 DERIVED

• Desai M, Rex DK, Bohm ME, Davitkov P, DeWitt JM, Fischer M, Faulx G, Heath R, Imler TD, James-Stevenson TN, Kahi CJ, Kessler WR, Kohli DR, McHenry L, Rai T, Rogers NA, Sagi SV, Sathyamurthy A, Vennalaganti P, Sundaram S, Patel H, Higbee A, Kennedy K, Lahr R, Stojadinovikj G, Dasari C, Parasa S, Faulx A, Sharma P. High-Definition Colonoscopy Compared With Cuff- and Cap-Assisted Colonoscopy: Results From a Multicenter, Prospective, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2023-2031.e6. doi: 10.1016/j.cgh.2021.12.037. Epub 2021 Dec 31.

  PMID: 34979245 DERIVED

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Prateek Sharma, MD

  Kansas City VA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by computer allocation
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three Arm Randomized Control Trial

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: May 16, 2019
• Study Start: March 16, 2018
• Primary Completion: December 20, 2021
• Study Completion: June 10, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)