A prospective, single arm, post market clinical follow-up of Extension Line & Needle Free Connector to explore safety and performance in Adult & Paediatric subjects in Indian Population. - NI

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4月29日

试验速览

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•1 Males and Females Adults & Paediatrics who are expected to require Exteena IV extension line with needle free connector & Safsite IV needle free connector for attachment to IV line
•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 having bleeding disorders condition where high pressure power injectors are used 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 Exteena IV extension line with needle free connector & Safsite IV needle free connector and its components
•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 breast feeding
•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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