Status:
UNKNOWN
Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy
Lead Sponsor:
Herrmann Apparatebau GmbH
Collaborating Sponsors:
CERES GmbH
Conditions:
Colonic Irrigation
Eligibility:
All Genders
18+ years
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-la...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04684082
Start Date
February 3 2021
End Date
March 30 2021
Last Update
February 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselerkrankungen
Leipzig, Germany, 04105