NL-OMON53534
Recruiting
Not Applicable
Exploratory Investigation on a Novel Catheter - NAV-0010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Wellspect HealthCare
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provision of informed consent.
- •2\. Female and male aged 18 \- 80 years.
- •3\. Patients successfully treated by TAI with Navina Smart system for at least 3
- •months and/or stable in therapy.
- •4\. Able to read, write and understand information given to them regarding the
Exclusion Criteria
- •1\. Involvement in the planning and conduct of the clinical investigation
- •(applies to both Wellspect HealthCare staff and staff at the study site).
- •2\. Previous enrolment in the present clinical investigation.
- •3\. Simultaneous participation in another clinical investigation, or
- •participation in a clinical investigation during the last month, that may
- •interfere with the present clinical investigation.
- •4\. Severe non\-compliance to Clinical Investigation Plan as judged by the
- •investigator and/or Wellspect HealthCare.
- •5\. Significant cardiovascular and/or other significant co\-morbidities which
- •could be negatively affected by the use of the investigational product.
Outcomes
Primary Outcomes
Not specified
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