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Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy

NCT04684082 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2021-02-08

No results posted yet for this study

Summary

This is a clinical study with a medical device that bears the CE mark (approval for marketing in the EU) and is applied within its intended use. It is a prospective, single-centre, single-arm, open-label, observational post-market clinical follow-up (PMCF) study using the "Colon Hydromat" system for bowel preparation prior to colonoscopy. The patients will be treated according to the clinical routine and in accordance with the current IFU.

Aim of the study is to confirm safety and performance (effectiveness) of colon hydrotherapy as bowel preparation for colonoscopy. Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation, especially for patients, who cannot tolerate oral preparations or want to have alternatives because they have experienced the current oral preparations as a burdensome process.

Conditions

  • Colonic Irrigation

Interventions

DEVICE

Colonic irrigation with the Colon Hydromat

A designated health professional will administer to the patient the colonic irrigation procedure - using the "Colon Hydromat" device, a CE certified device for colonic irrigation and cleansing before endoscopic procedures.

Sponsors & Collaborators

  • CERES GmbH

    collaborator INDUSTRY

  • Herrmann Apparatebau GmbH

    lead INDUSTRY

Principal Investigators

  • Niels Teich, Prof. Dr. med. · Study centre Leipzig - Internistic Joint Practice

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2021-03-15
Completion
2021-03-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684082 on ClinicalTrials.gov