Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Overview

The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

Full Title of Study: “Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.”

Study Type

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

Detailed Description

This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.

Interventions

  • Device: Endocuff Vision device
    • Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
  • Device: AmplifEYE device
    • Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.

Arms, Groups and Cohorts

  • Experimental: Endocuff Vision Arm
    • Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
  • Experimental: AmplifEYE Arm
    • Colonoscopy with AmplifEYE device attached to the distal end of the scope.

Clinical Trial Outcome Measures

Primary Measures

  • Number of Adenomas Detected Per Colonoscopy (APC).
    • Time Frame: During colonoscopy procedure
    • Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.

Secondary Measures

  • Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
    • Time Frame: During colonoscopy procedure
    • Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
  • Complications Encountered During Procedure
    • Time Frame: During Colonoscopy procedure
    • Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
  • Passage of Device Through Sigmoid Colon
    • Time Frame: during insertion portion of colonoscopy
    • Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
  • Polyps Per Colonoscopy (PPC)
    • Time Frame: During colonoscopy procedure
    • Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
  • Time Comparison for Each Method
    • Time Frame: During colonoscopy procedure
    • Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps. Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps. Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.
  • Cecal Intubation Rate
    • Time Frame: During Colonoscopy procedure
    • Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.
  • Detection of Serrated Lesions
    • Time Frame: During colonoscopy procedure
    • Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

Participating in This Clinical Trial

Inclusion Criteria

  • 40 years of age or older
  • Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
  • Able to provide written informed consent

Exclusion Criteria

  • Active Inflammatory Bowel Disease
  • Prior resection of the colon
  • Referred for resection of a polyp identified by another physician
  • Referred for a previous incomplete colonoscopy

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, Professor of Medicine – Indiana University
  • Overall Official(s)
    • Douglas K Rex, MD, Principal Investigator, Indiana University

References

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.

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