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

University of Naples

Status: Completed

Conditions: Adenomatous Polyps

Treatments: Device: EndoCuff-assisted colonoscopy; Device: Standard Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02374515

230/14

Details and patient eligibility

About

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.

Enrollment: 275 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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275 participants in 2 patient groups

Endocuff assisted Colonoscopy

Active Comparator group

Description:

Endocuff assisted Colonoscopy

Treatment:

Device: EndoCuff-assisted colonoscopy

Standard Colonoscopy

Active Comparator group

Description:

Standard colonoscopy

Treatment:

Device: Standard Colonoscopy