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NCT02374515 Clinical Trial

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

Adenomatous Polyps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02374515
Other study ID # 230/14
Secondary ID
Status Completed
Phase N/A
First received February 23, 2015
Last updated June 13, 2016
Start date February 2015
Est. completion date March 2016

Study information
Verified date June 2016
Source University of Naples
Contact n/a
Is FDA regulated No
Health authority Italy: University of Naples "Ethics Committee"
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 275
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• EndoCuff-assisted colonoscopy
Adenoma detection rate
• Standard Colonoscopy

Locations
Country Name City State
Italy University of Naples Federico II Naples

Sponsors (1)
Lead Sponsor Collaborator
University of Naples

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary adenoma detection rate 20 min. No
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