Bowel Management
Conditions
Brief 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.
Interventions
DEVICECP362 Test Catheter
The investigational device is intended to perform TAI procedures together with the CE-marked Peristeen Plus TAI system.
Sponsors
Coloplast A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has given written Informed Consent 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
1. Has known anal or colorectal stenosis 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Was it Possible to Perform Transanal Irrigation? | 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. |
Countries
Denmark
Participant flow
Recruitment details
Between April 2024 and July 2024, 20 users were recruited for the study from two sites and encompassed the Intention to treat (ITT) population.
Pre-assignment details
The 20 recruited participants were randomized into the two intervention arms. No participants were excluded or discontinued. No adverse events were reported.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total ITT Population | — |
|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 11.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Denmark | 20 participants | — |
| Sex: Female, Male Female | 15 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Evaluated at Visit 1 and Visit 2 (within a time duration of up to 17 days)
Population: The full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device - Newly Developed TAI Catheter. | Was it Possible to Perform Transanal Irrigation? | 20 Number of participants who replied YES |
| Comparator Device - Peristeen Plus | Was it Possible to Perform Transanal Irrigation? | 20 Number of participants who replied YES |