CTRI/2024/02/062232
Recruiting
Phase 4
A prospective, single arm, post market clinical follow-up of Closed Wound Drainage System to explore its safety and performance in Adult & Paediatric subjects in Indian Population. - NI
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Romsons Group Private Limited
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Males and Females Adult \& Paediatric who are expected to undergo surgery closed wound drainage procedures
- •2 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.
- •3 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
Exclusion Criteria
- •1 Subject who present with medical emergency where treatment is more priority than the informed consent process informed assent process
- •2 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
- •3 Any known allergy with any of the material of Closed Wound Drainage System and its components
- •4 Other conditions which in the opinion of investigators make the patient unsuitable for enrollment or could interfere with his her participation in and completion of the clinical investigation plan protocol
- •5 Subject who is pregnant or breastfeeding
- •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
Outcomes
Primary Outcomes
Not specified
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