STUDY OF LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY)

Phase 4

Not yet recruiting

• Conditions: Other specified urinary incontinence,

• Registration Number: CTRI/2022/04/042235
• Lead Sponsor: STERIMED MEDICAL DEVICES PVT LTD

Brief Summary

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|The purpose of the study is to characterize the safety, efficacy and performance of the LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY). People of any age undergoing general, gynecological, neuro, urethral and orthopedic surgeries (anesthesia patients) including use in plastic surgery that involve urine drainage from the bladder through urinary catheterization.

All the potential patients that have been catheterized with LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY).

A written informed consent will be taken from all study subjects.

All the subjects will be contacted telephonically for follow-up data.

Baseline, Procedural, and follow-up data will be collected and reported in the Case report form (CRF).

The data collected in CRF will be taken up for analysis and evaluation.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-04-27
• Study Start: 2022-04-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All subjects who undergo urinary catheterization.
• Both Male and Female patients will be enrolled.
• Patients who have been treated with LATEX FOLEY BALLOON CATHETER (2WAY & 3-WAY) -All patients who are willing to provide informed consent for participation in the study.

Exclusion Criteria

• Subjects not suitable for intervention with LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY).
• All subjects who are not willing to provide informed consent for participation in the study -Subjects having allergy to Latex -Subjects using silicone foley catheter.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate clinical safety and efficacy of the Latex Foley Balloon Catheter (2 Way and 3Way) and to observe any undesirable events under normal condition of use	3 Months

Secondary Outcome Measures

Name	Time	Method
To demonstrate the performance of Latex Foley Balloon Catheter (2 Way and 3Way)	3 months

Trial Locations

Locations (1)

Sagar Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Sagar Hospitals

🇮🇳Bangalore, KARNATAKA, India

Dr Mathangi KrishnaKumar

Principal investigator

9764062212

mathz89@gmail.com

DrCR Chandrashekara

Principal investigator

9845001061

drcrc2014@gmail.com