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This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | The investigational subjects are persons with anal incontinence or outlet problems and deemed suitable for and in need of low-volume TAI as assessed by the investigator or designee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navina Mini | Device | CE-marked Navina Mini, released on the market May 2023 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient Reported Outcome - Overall patient satisfaction when performing low- volume trans-anal irrigation measured with a 5-graded scale [0 = Not at all satisfied, 1 = Not satisfied, 2 = Neither satisfied nor unsatisfied, 3=Satisfied, 4 = Very satisfied] | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical benefit | Patient Reported Outcome on Fecal Incontinence and Defecation syndrome | 4 weeks |
| Ease of handling | Patient Reported Outcome on perception of handling the device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Banka Johnson, MD | University Hospital of Malmö, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital | Malmö | Sweden |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 4 weeks |
| Safety Outcome | Assessment of adverse events and device deficiencies | 4 weeks |