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Completed

NCT Number: NCT02345889

A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

About this study

Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Screening or Surveillance Colonoscopy

Exclusion criteria

  • Personal history of Colorectal cancer or Inflammatory bowel disease
  • Surgical resection of the colon or known colonic stricture
  • Personal or family history of Polyposis syndromes or Lynch syndrome
  • Referral for incomplete colonoscopy or known therapeutic polyp clearance
  • Severe diverticular disease
  • Referral for a positive hemoccult test in the past 6 months
  • Known coagulopathy
  • Inability to provide informed consent

Treatment and study plan

Colonoscopy with EndoCuff™

Device

colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope

FUSE® Colonoscopy

Device

colonoscopy performed with the FUSE® (full spectrum endoscopy) system

Colonoscopy with EndoRings™

Device

colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Standard Colonoscopy

Device

Current standard of care colonoscopy

Primary outcomes

  1. Adenomas Per Colonoscopy

    Time frame: During Procedure

Secondary outcomes

  1. Number of Participants With Detected Adenoma

    Time frame: During Procedure

  2. Percentage of Participants With Detected Adenoma

    Time frame: During Procedure

  3. Sessile Serrated Polyps Per Colonoscopy

    Time frame: During Procedure

  4. Number of Participants With Detected Sessile Serrated Polyp

    Time frame: During Procedure

    Number of patients with 1 or more sessile serrated polyps

  5. Percentage of Participants With Detected Sessile Serrated Polyp

    Time frame: During Procedure

  6. Number of Participants With a Detected Polyp

    Time frame: During Procedure

  7. Percentage of Participants With a Detected Polyp

    Time frame: During Procedure

  8. Cecal Insertion Time

    Time frame: During Procedure

  9. Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion

    Time frame: During Procedure

  10. Inspection Time

    Time frame: During Procedure

  11. Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.

    Time frame: During Procedure

  12. Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.

    Time frame: During Procedure

  13. Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.

    Time frame: During Procedure

  14. Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.

    Time frame: During Procedure

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

A 4-arm Randomized Controlled Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2015
Registry last updated
Mar 12, 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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