To explore safety and performance of Foley Balloon Catheter in Adult & Paediatric subjects in Indian population.

A prospective, single arm, multi-centric, post market clinical follow-up of Foley Balloon Catheter to explore its safety and performance in Adult & Paediatric subjects in Indian population. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/11/059401

Enrollment

100

Registered

2023-11-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 1.Uro Cath-2 Way a.Uro Cath (Adult) GS-1072 b.Uro Cath (Paediattric) GS-1090 2.Uro Cath-3 Way GS-1094 3.Foley Trac-2 Way a.Foley Trac (Adult) GS-1026 b.Foley Trac (Paediatric) GS-1022 4

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and Females (Adult & Paediatric) who are expected to require Foley Balloon Catheter short-term use urethral catheterization for urine drainage. 2. Subject who can provide Informed Consent Form (Adult) in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) can provide Informed Assent Form (Child). 3. The subject who is willing and able to comply with the requirement of the follow-up. OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who is willing and able to comply with the requirement of the follow-up.

Exclusion criteria

Exclusion criteria: 1. Subject who present with medical emergency, where treatment is more priority than the informed consent/informed assent process. 2. Subject with urethral trauma, urethral stricture, infection at site, severe phimosis, traumatic injury to the lower urinary tract, etc. 3. Subject, who cannot provide Informed Consent Form (Adult) such as unconscious, mentally challenged subject, OR in case of Paediatrics, parent of child/LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc. 4. Subject having urethral meatus / meatal stenosis. 5. Subjects having severe phimosis. 6. Subject having hypospadias. 7. Subject having high-riding prostate. 8. Any known allergy with any of the material of Foley Balloon Catheter and its component(s). 9. Other conditions, which in the opinion of investigating doctor make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the protocol. 10. Subject who is pregnant or breast feeding. 11. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 12. Participation in another research study involving an active investigation within 30 days prior to consent.

Design outcomes

Primary

Measure	Time frame
1. Insertion of catheter. 2. Inflation of Balloon. 3. Deflation of Balloon. 4. Drainage of urine. 5. Functioning of Non- return valve. 6. Compatibility of NRV with syringe luer. 7. Kinking of the catheter shaft. 8. Bleeding during insertion. 9. Insertion related pain. 10. Fitment of Foley Balloon Catheter with Urine Collection Bag connector. Timepoint: Device maximum use duration is 14 days.	—

Secondary

Measure	Time frame
1. Catheter material compatibility with body tissue / body fluid. 2. Balloon shape / symmetry on inflation prior to insertion. 3. Post removal physical characteristics of the catheter. 4. Presence of any encrustation. Timepoint: Device maximum use duration is 14 days.	—

Countries

India

Contacts

Public ContactDr Anoop Batra

Romsons Group Private Limited

singhalrohit10000@gmail.com8006599926

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026