Investigation of a New Rectal Catheter for Users of Transanal Irrigation
Not Applicable
Recruiting
- Conditions
- Bowel Management
- Interventions
- Device: CP362 Test Catheter
- 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
- RECRUITING
- 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
- Arm && Interventions
Group Intervention Description Investigational device - newly developed TAI catheter. CP362 Test Catheter -
- Primary Outcome Measures
Name Time Method The primary endpoint is: Was it possible to perform transanal irrigation (assessed after irrigation at V1 and V2) Up to 3 months This outcome will be answered with a Yes/No question.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Århus Universitetshospital
🇩🇰Århus, Jutland, Denmark
Amager Hvidovre Hospital
🇩🇰Hvidovre, Zealand, Denmark