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

NCT ID: NCT04684082

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-03
• Study Completion Date: 2021-03-30

Brief 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.

Detailed Description

This observational study is intended to answer the question, if the colon hydrotherapy (colonic irrigation with the "Colon Hydromat") works in real-life practice.

Colonic irrigation is regarded as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. The advantage of colonic irrigation is that there is no unpleasant taste, it avoids the discomfort of diarrheic episode and there is no need to drink a large volume of water or fluids. The patient will receive the bowel irrigation with the "Colon Hydromat" directly before colonoscopy, at the same day. Aim of this study is to confirm performance (effectiveness), in terms of an adequate bowel preparation and safety of the "Colon-Hydromat", as alternative bowel cleansing device prior to colonoscopy. The primary performance (effectiveness) endpoint for this study is the colonic cleanliness, defined as overall quality of bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS). The primary safety endpoints for this study are adverse device events (ADE) and serious adverse device effects (SADE), product and procedure related.

Conditions

Colonic Irrigation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Single Group Assignment

Patients will receive colonic irrigation as bowel preparation prior to colonoscopy.

Colonic irrigation with the Colon Hydromat

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with an indication of colonoscopy: inclusion is considered if patients require a colonoscopy and
• desire an alternative bowel preparation method to standard of oral polyethylene glycol or other orally taken purgatives, or do not tolerate the oral preparations, or had an inadequate colon cleansing following traditional oral preparation, in order to complete the colonoscopy at the same day.
• Adult patients (≥ 18 years old) having signed the informed consent.
• Being able to respond to the self-administered questionnaire.

Exclusion Criteria

• Psychiatric conditions and inability to provide informed consent
• Emergency colonoscopy
• Off-label use (application is not within the IFU)
• Pregnancy and lactation period
• The patient has one of the contraindications listed in the IFU.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CERES GmbH

INDUSTRY

Sponsor Role: collaborator

Herrmann Apparatebau GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels Teich, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Study centre Leipzig - Internistic Joint Practice

Locations

Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselerkrankungen

Leipzig, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Jochen Huebner

Role: CONTACT

jhuebner@hab.gmbh

+49 6022 65813

Facility Contacts

Niels Teich, Prof.

Role: primary

teich@igvs.de

+49 34204 7200

Other Identifiers

HRR015CHT

Identifier Type: -

Identifier Source: org_study_id