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Completed

NCT Number: NCT03418662

EndoRings Colonoscopy vs Standard Colonoscopy

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

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Key information

Conditions

Colorectal Adenoma Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Colorectal Polyp Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EndoRings device

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.

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. Problems Encountered With Equipment

    Time frame: During colonoscopy procedure

    Occurrences of slippage of EndoRings or of device being removed on insertion.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • US Endoscopy

Registry information

Official study title

A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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