EndoRings Colonoscopy for Adenoma Detection

NCT ID: NCT03469622

Last Updated: 2019-02-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-27

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.

EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EndoRings

Colonoscopy is performed with the EndoRings attached

Group Type ACTIVE_COMPARATOR

EndoRings

Intervention Type DEVICE

EndoRings-assisted colonoscopy

Standard Colonoscopy

Standard colonoscopy without any additional devices

Group Type ACTIVE_COMPARATOR

Standard colonoscopy

Intervention Type DEVICE

Standard colonoscopy without any additional devices

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EndoRings

EndoRings-assisted colonoscopy

Intervention Type DEVICE

Standard colonoscopy

Standard colonoscopy without any additional devices

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* indication for colonoscopy (screening, surveillance, diagnostic)
* age ≥ 45 years
* ability to give informed consent

Exclusion Criteria

* pregnancy
* age \<45 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
* s/p colonic resection
* bleeding disorder
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helios Albert-Schweitzer-Klinik Northeim

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tobias Meister, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

HELIOS Albert-Schweitzer Klinik

Ralf Kiesslich, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

HELIOS HSK Kliniken Wiesbaden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HELIOS HSK Kliniken

Wiesbaden, Hesse, Germany

Site Status RECRUITING

Department of Gastroenterology, University Medical Center

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

HELIOS St. Marienberg Klinik Helmstedt

Helmstedt, , Germany

Site Status RECRUITING

Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital

Northeim, , Germany

Site Status RECRUITING

HELIOS Medical Center Siegburg

Siegburg, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tobias Meister, Prof. Dr.

Role: CONTACT

+495551971244

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ralf Kiesslich, Prof. Dr.

Role: primary

+49611432420

Volker Ellenrieder, Professor

Role: primary

+49551390

Detlev Ameis, Prof.Dr.med.

Role: primary

0049 53 51 14 - 0

Tobias Meister, M.D.

Role: primary

00495551971244

Michael Schepke, Prof.Dr.med.

Role: primary

+49-2241-18-2226

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRC 047721

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Impact of AI on Trainee ADR
NCT05423964 UNKNOWN NA