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Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.

NCT02374515 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2016-06-15

No results posted yet for this study

Summary

This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.

Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

Conditions

  • Adenomatous Polyps

Interventions

DEVICE

EndoCuff-assisted colonoscopy

Adenoma detection rate

DEVICE

Standard Colonoscopy

Sponsors & Collaborators

  • University of Naples

    lead OTHER

Principal Investigators

  • Giovanni D. De Palma, MD · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Italy

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 NCT02374515 on ClinicalTrials.gov