Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

NCT03361917 | Completed Results DMC FDA Device

• 1 other identifier: 1709336500
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

Conditions

Colorectal Polyp; Colorectal Adenoma; Colon Cancer

Keywords

Colonoscopy screening; Colonscopy procedure

Outcome Measures

Primary Outcomes (1)

• Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)

  Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.

  During the withdrawal portion of the colonoscopy procedure

Secondary Outcomes (5)

• Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)

  During the insertion portion of the colonoscopy procedure

• Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)

  During the colonoscopy procedure

• Detection Rates

  During the colonoscopy procedure

• Polyps Per Colonoscopy

  During the colonoscopy procedure

• Boston Bowel Preparation Score

  During the withdrawal portion of the colonoscopy procedure after cleaning of the colon

Study Arms (2)

Control Arm (Standard Colonscopy)

NO INTERVENTION

Standard colonoscopy with no device attachments

Endocuff Vision

EXPERIMENTAL

Colonoscopy with Endocuff Vision attached to distal end of scope

Device: Endocuff Vision

Interventions

Endocuff Vision DEVICE

Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.

Endocuff Vision

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject referred for a screening or surveillance colonoscopy
• Subject is aged 40 years or older
• Subject has the 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 antiplatelet agents or anticoagulants that precludes the removal of polyps during the procedure
• History of polyposis syndrome or HNPCC
• Family history of colon cancer in a first-degree relative \< 60 years or two first degree relatives with colorectal cancer
• Inability to provide informed consent

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Tsiamoulos ZP, Misra R, Rameshshanker R, Elliott TR, Beintaris I, Thomas-Gibson S, Haycock A, Suzuki N, Rees C, Saunders BP. Impact of a new distal attachment on colonoscopy performance in an academic screening center. Gastrointest Endosc. 2018 Jan;87(1):280-287. doi: 10.1016/j.gie.2017.04.001. Epub 2017 Apr 13.

  PMID: 28412271 BACKGROUND

• Rex DK, Slaven JE, Garcia J, Lahr R, Searight M, Gross SA. Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jan;18(1):158-162.e1. doi: 10.1016/j.cgh.2019.01.015. Epub 2019 Jan 17.

  PMID: 30659990 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

Examiners were not blinded to the device used. Only 2 examiners with experience with the device participated in the study so generalizability of the results is unknown. Data was not collected on other potential confounders like smoking or BMI.

Results Point of Contact

• Title: Rachel Lahr
• Organization: Indiana University

rlahr@iu.edu

3179480724

Study Officials

• Douglas K Rex, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: December 11, 2017
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: August 6, 2019
• Results First Posted: May 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)