EndoRings Colonoscopy vs Standard Colonoscopy

Overview

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Full Title of Study: “A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 13, 2018

Detailed Description

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Interventions

  • Device: EndoRings device
    • Subjects randomized to undergo a colonoscopy procedure with the EndoRings 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 Colonoscopy)
    • Standard colonoscopy with no device attachment.
  • Experimental: EndoRings Colonoscopy
    • Colonoscopy with EndoRings device attached to the distal end of the scope.

Clinical Trial Outcome Measures

Primary Measures

  • Adenoma Detection Rates
    • Time Frame: During colonoscopy procedure
    • Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.
  • Number of Adenomas Per Colonoscopy
    • Time Frame: During colonoscopy procedure
    • Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.

Secondary Measures

  • Polyp Detection Rate
    • Time Frame: During colonoscopy procedure
    • Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.
  • Number of Detections Per Colonoscopy
    • Time Frame: During colonoscopy procedure
    • Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.
  • Total Number of Detections
    • Time Frame: During colonoscopy procedure
    • Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.
  • Cecal Intubation Rate
    • Time Frame: During colonoscopy procedure
    • Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.
  • Time Comparison for Each Method
    • Time Frame: During colonoscopy procedure
    • Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).
  • Patient Comfort Score
    • Time Frame: After colonoscopy was completed while patient was in recovery area of endoscopy unit
    • Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).
  • Problems Encountered With Equipment
    • Time Frame: During colonoscopy procedure
    • Occurrences of slippage of EndoRings or of device being removed on insertion.

Participating in This Clinical Trial

Inclusion Criteria

  • Screening or Surveillance Colonoscopy – Able to provide written informed consent Exclusion Criteria:

  • Known narrow colon or colon stenosis – Personal history of Colorectal cancer – History of inflammatory bowel disease – Familial adenomatous polyposis syndrome (FAP) – Hyperplastic polyposis syndrome – Referral for incomplete colonoscopy or polyp clearance

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Indiana University
  • Collaborator
    • US Endoscopy
  • 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

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