NCT04684082

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

Prospective, Single-center, Single-arm, Open-label Observational PMCF Study - Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 28 (estimated)
• Sponsor: Herrmann Apparatebau GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-03
• Primary completion: 2021-03-15
• Completion: 2021-03-30
• First posted: 2020-12-24
• Last updated: 2021-02-08

Locations

1 site across 1 country: Germany