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| Name | Class |
|---|---|
| CERES GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group Assignment | Patients will receive colonic irrigation as bowel preparation prior to colonoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonic irrigation with the Colon Hydromat | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of bowel preparation (Colonic Cleanliness), evaluated through the Boston Bowel Preparation Scale (BBPS). | Quality of bowel preparation validated by numerical scale for bowel cleanse (0-9 best) | day 1 |
| Adverse device events (ADE) and collection of SADE (device or procedure related). | Assessment of ADE: Patients will be asked in questionnaires, if they had any adverse events, especially nausea, vomiting, pain/cramps, dizziness and headache and rate of patients where colonic irrigation had to be aborted. Assessment of SADE: will be assessed at end of colonoscopy by investigator. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| BBPS for each segment. | BBPS will be assessed in each bowel segment (left, transverse, right). | day 1 |
| Patient satisfaction. | Patient satisfaction with respect to convenience and comfort/ discomfort, and preference/acceptance, as evaluated by a questionnaire (questions to the patient; no score). |
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Inclusion Criteria:
Exclusion Criteria:
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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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jochen Huebner | Contact | +49 6022 65813 | jhuebner@hab.gmbh |
| Name | Affiliation | Role |
|---|---|---|
| Niels Teich, Prof. Dr. med. | Study centre Leipzig - Internistic Joint Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselerkrankungen | Recruiting | Leipzig | 04105 | Germany |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 12, 2022 | |
| Reset | Jul 28, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 12, 2022 | Jul 28, 2023 |
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| day 1 |
| User satisfaction and usability. | User satisfaction and usability, as measured by a questionnaire (questions to the patient; no score). | day 1 |
| Details to colonic irrigation. | Time taken to complete the colon irrigation with the "Colon Hydromat". | day 1 |
| Details to colonic irrigation. | Number of cycles used for cleaning the colon. | day 1 |
| Details to colonic irrigation. | Volume of water used for cleaning the colon. | day 1 |
| Colonoscopic findings. | Characteristics of all polyps/lesions detected: Location (right, transverse, or left colon) and size. General assessment of colon anatomy and other circumstances related to the colon: No abnormality detected / tortuous / very long/ diverticular disease / stenosis / severe constipation / weak muscle tone of the sphincter - build-up of pressure was insufficient. | day 1 |
| Rate of colonoscopy termination. | Rate of colonoscopy termination due to inadequate bowel preparation. | day 1 |
| Procedure time of colonoscopy. | Procedure time of colonoscopy (time from intubation to withdrawal). | day 1 |
| Withdrawal time. | Withdrawal time: the total time for withdrawal from cecum to anus; this includes all interventions or delays (e.g. biopsies, polypectomies…). | day 1 |
| Cecal intubation rate. | Cecal intubation rate (reaching the cecum or anastomosis, if present). | day 1 |
| Runway time. | Time interval between the patient's end of bowel cleaning / colonic irrigation and the moment of colonoscope insertion. | day 1 |