To check safety and performance of Extension Line in Adult & Paediatric subjects in Indian Population.
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/10/059246
- 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 Extension Line for administration of intravenous infusions.
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 present with medical emergency, where treatment is more priority than the informed consent/informed assent process.
2.Subject, who cannot provide Informed Consent Form (Adult) in general such as unconscious, mentally challenged subject, vulnerable 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 of material of Extension Line and its component(s).
4.Any other contra-indication pertaining to the use of Extension Line.
5.Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his/her participation in, and completion of the clinical investigation plan.
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