A prospective, single arm, multi-centric, post market clinical follow-up of Extension Line to explore its safety and performance in Adult & Paediatric subjects in Indian Population. - Nil

Romsons Group Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•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.

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