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

A prospective, observational and multi-center study to characterize the safety, efficacy and performance of the LATEX FOLEY BALLOON CATHETER (2-WAY & 3-WAY)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/04/042235
Enrollment
80
Registered
2022-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N394- Other specified urinary incontinence

Interventions

Intervention1: Nil: Nil

Sponsors

STERIMED MEDICAL DEVICES PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 useTimepoint: 3 Months

Secondary

MeasureTime frame
To demonstrate the performance of Latex Foley Balloon Catheter (2 Way and 3Way)Timepoint: 3 months

Countries

India

Contacts

Public ContactDr C R Chandrashekara

Anesthesiologist in Sagar hospitals

drcrc2014@gmail.com9845001061

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026