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Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study

NCT01955122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2017-03-06

Study results available
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Summary

To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy.

To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.

Conditions

Interventions

DEVICE

Tandem Colonoscopy

Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order.

Sponsors & Collaborators

  • EndoAid

    lead INDUSTRY

Principal Investigators

  • Meytal Segev, DMD · EndoAid Ltd.

  • Ian Gralnek, Prof. · Rambam Health Care Campus

  • Ori Segol, Dr. · Carmel Medical Center

  • Peter Siersema, Prof. · UMC Utrecht

  • Douglas K. Rex, Dr. · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States
  • Israel
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT01955122 on ClinicalTrials.gov