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An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.
In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.
Each subject will be followed during approximately one week, depending on the usual time between their TAI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | Transanal irrigation (TAI) with new catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanal irrigation (TAI) | Device | Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Catheter stay in place | Does the catheter stay in place during water instillation? Yes/No | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel emptying performance | Evaluation of bowel emptying performance: Subject's perception of emptying of bowel similar to regular use of TAI. Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study. Question asked: "What is the subject's perception of emptying of bowel with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events and Device Deficiencies | To evaluate the safety of catheter by assessment of incidence and severity of Adverse Events (AEs, SAEs, ADEs, SADEs, USADEs) and Device Deficiencies occurring during the study period. | 1 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Han-Geurts, MD | Proctos Kliniek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proctos Kliniek | Bilthoven | MB Bilthoven | 3723 | Netherlands |
IPD available will not be available to other researchers.
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Proof of concept investigation with subjects experienced in using transanal irrigation with a balloon catheter.
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| 1 week |
| Leakage | Evaluation of leakage during water instillation: Subject's perception of leakage similar to regular use of TAI. Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study. Question asked: "What is the subject's perception of leakage with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better | 1 week |