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

Phase 4

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2023/11/059401
• Lead Sponsor: Romsons Group Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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