Investigation of a New Rectal Catheter for Users of Transanal Irrigation
Launched by COLOPLAST A/S · Apr 26, 2024
Trial Information
Current as of June 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Has given written Informed Consent
- • 2. Is at least 18 years old
- • 3. Has full legal capacity
- • 4. Has used Trans Anal Irrigation (TAI) with balloon catheter for at least 4 weeks prior to inclusion
- • 5. Performs TAI minimum 3 times/week
- • 6. Is able to follow study procedures assessed by investigator
- Exclusion Criteria:
- • 1. Has known anal or colorectal stenosis
- • 2. Has active/recurrent colorectal cancer
- • 3. Is within 3 months of anal or colorectal surgery
- • 4. Is within 4 weeks of endoscopic polypectomy
- • 5. Has ischaemic colitis
- • 6. Has acute inflammatory bowel disease
- • 7. Has acute diverticulitis
- • 8. Is participating in any other clinical study that may interfere with this study (assessed by investigator).
- • 9. Is pregnant or breastfeeding
About Coloplast A/S
Coloplast A/S is a leading global medical device company headquartered in Denmark, specializing in products and services for individuals with intimate healthcare needs. With a strong commitment to innovation, Coloplast develops solutions in areas such as ostomy care, urology, and wound care. The company prioritizes patient-centered design, combining advanced technology with user-friendly applications to enhance quality of life for patients. Coloplast A/S actively conducts clinical trials to validate the safety and efficacy of its products, ensuring they meet the highest standards of care and contribute to improved health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
århus, Jutland, Denmark
Hvidovre, Zealand, Denmark
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported