To explore safety and performance of Thoracic Trocar Catheter in Adult & Paediatric subjects in Indian Population.

Phase 4

Recruiting

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

• Registration Number: CTRI/2023/10/059216
• Lead Sponsor: Romsons Group Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• 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 & Pediatric) who are expected to require Thoracic Trocar Catheter.

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 Pediatrics, 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 Pediatrics, 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 bleeding disorder, extensive malignant skin involvement, multicoated effusions, located fluid accumulations, hepatic hydrothorax.

3.Subject, who cannot provide Informed Consent Form (Adult) such as unconscious, mentally challenged subject, OR in case of Pediatrics, parent of child/LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission etc.

4.Any known allergy with any of the material of Thoracic Trocar Catheter and its component(s).

5.Subject who is pregnant or breast feeding.

6.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.

7.Participation in another research study involving an active investigation within 30 days prior to consent.

Study & Design

• Study Type: PMS
• Study Design: Not specified