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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Peristeen Plus | No Intervention | Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP362 Test Catheter | Device | The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Århus Universitetshospital | Aarhus | Jutland | 8200 | Denmark | ||
| Amager Hvidovre Hospital |
The 20 recruited participants were randomized into the two intervention arms. No participants were excluded or discontinued. No adverse events were reported.
Between April 2024 and July 2024, 20 users were recruited for the study from two sites and encompassed the Intention to treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Device Then Comparator Device | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 4. At the first intervention the transanal irrigation (TAI) procedure was performed with the CP362 Test Catheter together with the CE-marked Peristeen® Plus TAI system, then, at the second intervention the TAI procedure was performed with the Comparator catheter, the Peristeen® Plus rectal balloon catheter, together with the CE-marked Peristeen® Plus TAI system. |
| FG001 | Comparator Device Then Investigational Device | Participants were randomly assigned to the sequence of two intervention arms, in block sizes of 4. At the first intervention the transanal irrigation (TAI) procedure was performed with the Comparator catheter, the Peristeen® Plus rectal balloon catheter, together with the CE-marked Peristeen® Plus TAI system, then, at the second intervention the TAI procedure was performed with CP362 Test Catheter together with the CE-marked Peristeen® Plus TAI system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
| |||||||||||||
| Visit 2 |
|
[Not Specified]
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| ID | Title | Description |
|---|---|---|
| BG000 | Total ITT Population | Each investigation arm consisted of two test visits. On each visit, the participants underwent one TAI procedure with either the CP362 test catheter or the Comparator catheter, according to the randomization scheme. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set | Posted | Number | Number of participants who replied YES | Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Schnipper, Medical Writer | Coloplast A/S | 004549111257 | dkjuls@coloplast.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2024 | May 7, 2025 | Prot_SAP_000.pdf |
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| Hvidovre |
| Region Sjælland |
| 2650 |
| Denmark |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Comparator Catheter - Peristeen Plus | Comparator catheter: The Peristeen® Plus rectal balloon catheter is used together with the CE-marked Peristeen® Plus TAI system. | 0 | 20 | 0 | 20 | 0 | 20 |
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