Investigation of a New Rectal Catheter for Users of Transanal Irrigation
Not Applicable
Completed
- Conditions
- Bowel Management
- Registration Number
- NCT06389396
- Lead Sponsor
- Coloplast A/S
- Brief Summary
The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.
The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Has given written Informed Consent
- Is at least 18 years old
- Has full legal capacity
- Has used Trans Anal Irrigation (TAI) with balloon catheter for at least 4 weeks prior to inclusion
- Performs TAI minimum 3 times/week
- Is able to follow study procedures assessed by investigator
Exclusion Criteria
- Has known anal or colorectal stenosis
- Has active/recurrent colorectal cancer
- Is within 3 months of anal or colorectal surgery
- Is within 4 weeks of endoscopic polypectomy
- Has ischaemic colitis
- Has acute inflammatory bowel disease
- Has acute diverticulitis
- Is participating in any other clinical study that may interfere with this study (assessed by investigator).
- Is pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Was it Possible to Perform Transanal Irrigation? Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days) After visit 1 and visit 2, the primary endpoint, defined as if it was possible to perform transanal irrigation, was answered by a yes/no answer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Århus Universitetshospital
🇩🇰Århus, Jutland, Denmark
Amager Hvidovre Hospital
🇩🇰Hvidovre, Zealand, Denmark
Århus Universitetshospital🇩🇰Århus, Jutland, Denmark