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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02374515

Enrollment

275

Registered

2015-02-27

Start date

2015-02-28

Completion date

2016-03-31

Last updated

2016-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomatous Polyps

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.

Interventions

DEVICEEndoCuff-assisted colonoscopy

Adenoma detection rate

DEVICEStandard Colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
adenoma detection rate	20 min.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026