EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

NCT ID: NCT02034929

Last Updated: 2018-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-07-31

Brief Summary

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The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.

The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.

The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.

Detailed Description

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Conditions

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Polyp Adenoma Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Endocuff-assisted colonoscopy

Endocuff-assisted colonoscopy

Group Type ACTIVE_COMPARATOR

EndoCuff-assisted colonoscopy

Intervention Type DEVICE

EC-assisted colonoscopy

Standard colonoscopy

Standard Colonoscopy

Group Type ACTIVE_COMPARATOR

Standard colonoscopy

Intervention Type DEVICE

Standard colonoscopy

Interventions

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EndoCuff-assisted colonoscopy

EC-assisted colonoscopy

Intervention Type DEVICE

Standard colonoscopy

Standard colonoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent

Exclusion Criteria

* pregnancy
* age\<18 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
* s/p colonic resection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helios Albert-Schweitzer-Klinik Northeim

OTHER

Sponsor Role lead

Responsible Party

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Tobias Meister

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tobias Meister, M.D.

Role: PRINCIPAL_INVESTIGATOR

Helios Albert-Schweitzer-Hospital

Locations

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University Medical Center Göttingen

Göttingen, , Germany

Site Status

HELIOS St. Marienberg Hospital Helmstedt

Helmstedt, , Germany

Site Status

Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital

Northeim, , Germany

Site Status

HELIOS Medical Center Siegburg, Department of Gastroenterology

Siegburg, , Germany

Site Status

Countries

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Germany

References

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Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.

Reference Type DERIVED
PMID: 25470133 (View on PubMed)

Other Identifiers

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HRS ID 003053

Identifier Type: -

Identifier Source: org_study_id

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