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

Not Applicable

Completed

• Conditions: Adenomatous Polyps
• Interventions: Device: Standard Colonoscopy; Device: EndoCuff-assisted colonoscopy

• Registration Number: NCT02374515
• Lead Sponsor: University of Naples

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Colonoscopy	Standard Colonoscopy	Standard colonoscopy
Endocuff assisted Colonoscopy	EndoCuff-assisted colonoscopy	Endocuff assisted Colonoscopy

Primary Outcome Measures

Name	Time	Method
adenoma detection rate	20 min.

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy