A Study of 100% Silicone Foley Balloon Catheter
Phase 4
- Conditions
- Health Condition 1: N394- Other specified urinary incontinence
- Registration Number
- CTRI/2022/04/042015
- Lead Sponsor
- Sterimed Surgicals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All subjects who undergo urinary catheterization.
-Both Male and Female patients will be enrolled.
-Patients who have been treated with 100% SILICONE FOLEY BALLOON CATHETER (2WAY & 3-WAY)
-All patients who are willing to provide informed consent for participation in the study
-Pediatric population using silicone foley catheter
Exclusion Criteria
-Subjects not suitable for intervention with 100% SILICONE FOLEY BALLOON CATHETER (2-WAY & 3-WAY).
-All subjects who are not willing to provide informed consent for participation in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate clinical safety and efficacy of the 100% Silicone Foley Balloon Catheter (2 Way / 3Way) and to observe any undesirable events under normal condition of use.Timepoint: 6 Months
- Secondary Outcome Measures
Name Time Method To demonstrate the performance of 100% Silicone Foley Balloon Catheter (2 Way / 3Way)Timepoint: 6 Months