Evaluation of Performance and Safety of Colonic Irrigation With the Colon Hydromat as a Non-oral Bowel Preparation for Colonoscopy
Launched by HERRMANN APPARATEBAU GMBH · Dec 21, 2020
Trial Information
Current as of August 02, 2025
Unknown status
Keywords
ClinConnect Summary
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 t...
Gender
ALL
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.
About Herrmann Apparatebau Gmbh
Herrmann Apparatebau GmbH is a reputable clinical trial sponsor specializing in the development and manufacturing of innovative medical devices and technologies. With a commitment to advancing healthcare solutions, the company focuses on enhancing patient outcomes through rigorous research and development processes. Herrmann Apparatebau GmbH is dedicated to adhering to the highest regulatory standards and ethical practices, ensuring that its clinical trials are conducted with integrity and precision. By collaborating with healthcare professionals and leveraging cutting-edge technology, the company aims to contribute significantly to the improvement of medical treatments and patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leipzig, , Germany
Patients applied
Trial Officials
Niels Teich, Prof. Dr. med.
Principal Investigator
Study centre Leipzig - Internistic Joint Practice
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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