An interventional study of CP362 Test Catheter in Bowel Management, sponsored by Coloplast A/S. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Coloplast A/S · Not applicable, Interventional, and Prevention
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.
Coloplast A/S is the lead sponsor of 146 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CP362 Test Catheter: The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system.
Device: CP362 Test Catheter
Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system.
The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.
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.
Time frame: Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)
Between April 2024 and July 2024, 20 users were recruited for the study from two sites and encompassed the Intention to treat (ITT) population.
| Milestone | Investigational Device Then Comparator Device | Comparator Device Then Investigational Device |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
| Milestone | Investigational Device Then Comparator Device | Comparator Device Then Investigational Device |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| Number of participants who replied YES | Investigational Device - Newly Developed TAI Catheter. | Comparator Device - Peristeen Plus |
|---|---|---|
| Was it Possible to Perform Transanal Irrigation? | 20 | 20 |
Collected over Adverse events were registered from the individual's enrolment until termination in the study. The total study duration for the individual subject was between two to 17 days, consisting of three site visits (V0-V2), where V0 and V1 could be performed the same day.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Device - Newly Developed TAI Catheter. | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Comparator Catheter - Peristeen Plus | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
\[Not Specified\]
| Age, Continuous(years) | Total ITT Population |
|---|---|
| Mean | 61 ± 11.3 |
| Sex: Female, Male(Participants) | Total ITT Population |
|---|---|
| Female | 15 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Total ITT Population |
|---|
| Region of Enrollment(participants) | Total ITT Population |
|---|---|
| Denmark | 20 |
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Coloplast A/S