Investigation of a New Rectal Catheter for Users of Transanal Irrigation
NCT ID: NCT06389396
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-04-08
2024-07-30
Brief Summary
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The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Investigational device - newly developed TAI catheter.
CP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system.
CP362 Test Catheter
The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.
Peristeen Plus
Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system.
No interventions assigned to this group
Interventions
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CP362 Test Catheter
The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Coloplast A/S
INDUSTRY
Responsible Party
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Locations
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Århus Universitetshospital
Aarhus, Jutland, Denmark
Amager Hvidovre Hospital
Hvidovre, Region Sjælland, Denmark
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP362
Identifier Type: -
Identifier Source: org_study_id
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