Trial Outcomes & Findings for Investigation of a New Rectal Catheter for Users of Transanal Irrigation (NCT NCT06389396)
NCT ID: NCT06389396
Last Updated: 2025-06-12
Results Overview
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.
COMPLETED
NA
20 participants
Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)
2025-06-12
Participant Flow
Between April 2024 and July 2024, 20 users were recruited for the study from two sites and encompassed the Intention to treat (ITT) population.
The 20 recruited participants were randomized into the two intervention arms. No participants were excluded or discontinued. No adverse events were reported.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Visit 1
STARTED
|
10
|
10
|
|
Visit 1
COMPLETED
|
10
|
10
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
|
Visit 2
STARTED
|
10
|
10
|
|
Visit 2
COMPLETED
|
10
|
10
|
|
Visit 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total ITT Population
n=20 Participants
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.
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11.3 • n=20 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
|
Region of Enrollment
Denmark
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)Population: The full analysis set
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.
Outcome measures
| Measure |
Investigational Device - Newly Developed TAI Catheter.
n=20 Participants
The CP362 Test Catheter, the investigational device, was used to perform TAI procedures together with the CE-marked Peristeen® Plus TAI system.
|
Comparator Device - Peristeen Plus
n=20 Participants
Comparator catheter. The Peristeen® Plus rectal balloon catheter, was used together with the CE-marked Peristeen® Plus TAI system.
|
|---|---|---|
|
Was it Possible to Perform Transanal Irrigation?
|
20 Number of participants who replied YES
|
20 Number of participants who replied YES
|
Adverse Events
Investigational Device - Newly Developed TAI Catheter.
Comparator Catheter - Peristeen Plus
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place