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

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.

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Key information

Conditions

Adenomatous Polyps Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion criteria

Pregnancy
age<18 years
age > 80 years
known colonic strictures
chronic inflammatory bowel disease
active inflammation

Treatment and study plan

EndoCuff-assisted colonoscopy

Device

Adenoma detection rate

Other names: EC-assisted colonoscopy

Standard Colonoscopy

Device

Primary outcomes

adenoma detection rate

Time frame: 20 min.

Sponsors and collaborators

Lead sponsor

University of Naples

Other

Registry information

Official study title

Endocuff-assisted Colonoscopy: a Randomized Back-to-back Colonoscopy Study of Adenoma Detection.

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 27, 2015
Registry last updated: Jun 15, 2016

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.

Published trials that share one or more normalized conditions with this study.

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