Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Overview

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

Full Title of Study: “Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 18, 2018

Detailed Description

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Interventions

  • Device: Endocuff Vision
    • 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.

Arms, Groups and Cohorts

  • No Intervention: Control Arm (Standard Colonscopy)
    • Standard colonoscopy with no device attachments
  • Experimental: Endocuff Vision
    • Colonoscopy with Endocuff Vision attached to distal end of scope

Clinical Trial Outcome Measures

Primary Measures

  • Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)
    • Time Frame: During the withdrawal portion of the colonoscopy procedure
    • 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.

Secondary Measures

  • Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)
    • Time Frame: During the insertion portion of the colonoscopy procedure
    • Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.
  • Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)
    • Time Frame: During the colonoscopy procedure
    • Total procedure time is the time from the initial insertion through the complete withdrawal of the scope
  • Detection Rates
    • Time Frame: During the colonoscopy procedure
    • The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.
  • Polyps Per Colonoscopy
    • Time Frame: During the colonoscopy procedure
    • Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.
  • Boston Bowel Preparation Score
    • Time Frame: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon
    • Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist.

Participating in This Clinical Trial

Inclusion Criteria

  • Subject referred for a screening or surveillance colonoscopy
  • Subject is aged 40 years or older
  • Subject has the ability to provide informed consent

Exclusion Criteria

  • 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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Douglas K. Rex, Distinguished Professor – Indiana University
  • Overall Official(s)
    • Douglas K Rex, MD, Principal Investigator, Indiana University

References

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.

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