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

NCT02345889 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1262

Last updated 2019-03-12

Study results available
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Summary

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

Conditions

  • Colorectal Neoplasms

Interventions

DEVICE

Colonoscopy with EndoCuff™

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

DEVICE

FUSE® Colonoscopy

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

DEVICE

Colonoscopy with EndoRings™

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

DEVICE

Standard Colonoscopy

Current standard of care colonoscopy

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Douglas Rex, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345889 on ClinicalTrials.gov