A prospective, single arm, multi-centric, post market clinical follow-up of Central Venous Catheter Kit to explore its safety and performance in Adult and Paediatric subjects in Indian population.

Romsons Group Private Limited0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1.Males and Females (Adult & Paediatric) who are expected to require Central Venous Catheterization for provision of short term intravenous infusion of parenteral fluids, medication, nutrition, chemotherapy, blood transfusion, sampling, etc.
•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 disorders, coagulopathy, infection at the site, distorted local anatomy 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 Central Venous Catheter Kit and its component(s).
•5.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.
•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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