Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02331836

Acronym

EC-Cap-SC

Enrollment

561

Registered

2015-01-06

Start date

2015-02-28

Completion date

2019-02-01

Last updated

2019-02-12

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

Conditions

Colorectal Polyps, Colorectal Adenomas

Keywords

adenoma detection rate, polyp detection rate, withdrawal time, coecal and ileum intubation rate

Brief summary

Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

Detailed description

The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Interventions

DEVICEArc Endocuff (AEC 110, 120, 130, 140)

DEVICECap

Olympus Disposable distal attachment 15mm diameter, 4mm depth

DEVICEStandard colonoscope

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Colonoscopy independent from indication * Age ≥ 18 * Patient is able to provide informed consent for the procedure

Exclusion criteria

* Inflammatory Bowel Disease stenosis * Pregnant of nursing patient * Acute diverticulitis * Active Inflammatory Bowel Disease * Age ≤ 18 * Coagulation disorder (INR\>1.4 , Thrombocytes \< 50000/µl)

Design outcomes

Primary

Measure	Time frame	Description
Adenoma detection rate	1 year	Proportion of patients having at least one adenoma
Polyp detection rate	1 year	Proportion of patients having at least one adenoma

Secondary

Measure	Time frame
Ileum intubation rate	one year
Coecum intubation time	one day
withdrawal time	one day
Bowel preparation result	one day
severe bleeding	one day
perforation	one day
mucosal laceration	one day
Coecum intubation rate	one year

Countries

Germany, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026