Bowel ManagementNCT06389396
Investigation of a New Rectal Catheter for Users of Transanal Irrigation
A study testing CP362 Test Catheter in people with Bowel Management, run by Coloplast A/S at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Management
- What is being tested?
- CP362 Test Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesDenmark
- Study dates
- 8 Apr 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Has acute diverticulitis
- Is participating in any other clinical study that may interfere with this study (assessed by investigator).
- Is pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Århus Universitetshospital
Aarhus, Jutland, 8200
Amager Hvidovre Hospital
Hvidovre, Region Sjælland, 2650
About this study
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.
- Conditions
- Bowel Management
- Being tested
- CP362 Test Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP362 Test CatheterDevice
The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device - newly developed TAI catheter. | Experimental | CP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system. Receives: Device: CP362 Test Catheter |
| Peristeen Plus | No intervention | Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Was it Possible to Perform Transanal Irrigation?
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.
Measured: Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start8 Apr 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bowel ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389396
- Sponsor's protocol ID
- CP362
- Status last verified
- May 2025
- First submitted
- 11 Apr 2024
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a New Rectal Catheter for Users of Transanal Irrigation
- ClinicalTrials.gov ID
- NCT06389396
- Acronym / sponsor ID
- CP362
- Conditions
- Bowel Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational device - newly developed TAI catheter. | Experimental | Device: CP362 Test CatheterCP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system. |
| Peristeen Plus | No intervention | –Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP362 Test CatheterThe investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system. | Device | Investigational device - newly developed TAI catheter. |
Primary outcome
Was it Possible to Perform Transanal Irrigation?
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CP362 Test Catheter in people with Bowel Management, run by Coloplast A/S at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Was it Possible to Perform Transanal Irrigation? (time frame: Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.