Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?

NCT ID: NCT03385434

Last Updated: 2020-06-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-02-01

Brief Summary

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Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate).

Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.

This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).

Detailed Description

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Conditions

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Colonic Adenoma Colonic Polyp Colonic Neoplasms Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Endorings-assisted screening colonoscopy

146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy.

Group Type EXPERIMENTAL

Endorings-2

Intervention Type DEVICE

292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).

Standard screening colonoscopy

146 patients with an indication for screening endoscopy will receive a standard colonoscopy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endorings-2

292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).

Intervention Type DEVICE

Other Intervention Names

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Endorings-2 (EndoAid Ltd, Caesarea, Israel)

Eligibility Criteria

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Inclusion Criteria

* Patients with an indication for a screening colonoscopy.

Exclusion Criteria

* Patients under 18 years, pregnancy
* Patients with prior colectomy or partial colectomy
* Patients with a history of colorectal cancer
* Patients with hereditary polyposis syndromes (FAP, HNPCC)
* Patients with a stricture of the colon
* Patients receiving anticoagulation prohibiting a colonoscopy
* inability to have a patient education
* bad conditions prohibiting a colonoscopy
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Unversity Clinic Muenster

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Frank Lenze, MD

Role: CONTACT

+492518357935

Arne Bokemeyer, MD

Role: CONTACT

+492518357935

Facility Contacts

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Frank Lenze, MD, PhD

Role: primary

00492518358103

Other Identifiers

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2017-635-f-S

Identifier Type: -

Identifier Source: org_study_id

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