To explore safety and performance of Infusion Set for administration of intravenous fluids in Adult & Paediatric subjects in Indian Population.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/10/046321
- Lead Sponsor
- Romsons Group Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Males and Females (Adult & Paediatric) who are expected to require Infusion Set.
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 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 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 hydrithorax.
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 Infusion Set 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
- Primary Outcome Measures
Name Time Method Successful Completion of Infusion Set in the target population.Timepoint: up to 3 days /72 hours
- Secondary Outcome Measures
Name Time Method ATimepoint: NA