NCT05644912
Completed
Not Applicable
Exploratory Investigation on a Novel Catheter
ConditionsBowel Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bowel Dysfunction
- Sponsor
- Wellspect HealthCare
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Catheter stay in place
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of informed consent.
- •Female and male aged 18-80 years.
- •Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
- •Patients considered suitable to participate by investigator.
- •Able to read, write and understand information given to them regarding the study.
Exclusion Criteria
- •Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
- •Previous enrolment in the present clinical investigation.
- •Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
- •Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
- •Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
- •Known anal or colorectal stenosis.
- •Active inflammatory bowel disease.
- •Acute diverticulitis.
- •Colorectal cancer.
- •Ischemic colitis.
Outcomes
Primary Outcomes
Catheter stay in place
Time Frame: 1 week
Does the catheter stay in place during water instillation? Yes/No
Secondary Outcomes
- Bowel emptying performance(1 week)
- Leakage(1 week)
Study Sites (1)
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