Clinical trial NCT04684082: Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Irrigation
Keywords: Colon Hydrotherapy
Colonoscopy
Lead sponsor: Herrmann Apparatebau GmbH
Sponsor class: INDUSTRY
Collaborators: name: CERES GmbH
First posted: 2020-12-24
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients (men and women) who are planned for a colonoscopy and where anorectal colonic irrigation with the specula can be performed, will be included into the study.

The colonic irrigation is regarded as alternative bowel preparation to oral preparations, especially for patients who:

* cannot tolerate oral preparations (e.g. cannot drink large volumes, nausea, vomiting), or
* want to have alternatives because they have experienced the current oral preparations as a burdensome process, or
* had an inadequate colon cleansing following traditional oral preparation, in order to complete the colonoscopy at the same day.

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.

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.

Primary outcomes:
measure: Quality of bowel preparation (Colonic Cleanliness), evaluated through the Boston Bowel Preparation Scale (BBPS).
timeFrame: day 1
measure: Adverse device events (ADE) and collection of SADE (device or procedure related).
timeFrame: day 1
Secondary outcomes:
measure: BBPS for each segment.
timeFrame: day 1
measure: Patient satisfaction.
timeFrame: day 1
measure: User satisfaction and usability.
timeFrame: day 1
measure: Details to colonic irrigation.
timeFrame: day 1
measure: Details to colonic irrigation.
timeFrame: day 1
measure: Details to colonic irrigation.
timeFrame: day 1
measure: Colonoscopic findings.
timeFrame: day 1
measure: Rate of colonoscopy termination.
timeFrame: day 1
measure: Procedure time of colonoscopy.
timeFrame: day 1
measure: Withdrawal time.
timeFrame: day 1
measure: Cecal intubation rate.
timeFrame: day 1
measure: Runway time.
timeFrame: day 1
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselerkrankungen
Study officials:
affiliation: Study centre Leipzig - Internistic Joint Practice
name: Niels Teich, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: