To explore safety and performance of Yankaur Suction Set & Accessories in Adult & Paediatric subjects in Indian Population.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/01/062056
- Lead Sponsor
- Romsons Group Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Males and Females Adult & Paediatric who are expected to require use of Yankaur Suction Set & Accessories Vaccu Suck Suction Set & Accessories for per-operative suctioning needed for removal of surgical debris secretions blood during surgical procedure.
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.
1 Subject who is present with medical emergency, where treatment is more priority than the informed consent informed assent process.
2 Subject with severe conditions like bleeding disorder coagulopathy 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 Any known allergy with any of the material of the device Yankaur Suction Set & Accessories Vaccu Suck Suction Set & Accessories and or its components.
5 Other conditions which in the opinion of investigators make the patient unsuitable for enrolment or could interfere with his her participation and in completion of the clinical investigation plan protocol.
6 Subject who is pregnant or breastfeeding.
7 Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
8 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
- Secondary Outcome Measures
Name Time Method