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.

Romsons Group Private Limited1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2024年2月15日最近更新: 2024年4月1日

试验速览

阶段: Unknown
状态: 已完成
发起方: Romsons Group Private Limited
入组人数: 100
试验地点: 1
主要终点: The Primary End Point of the study are as

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a prospective, post marketing clinical follow-up of Exteena (I.V. extension line with needle free connector) & Safsite (I.V needle free connector) to explore the safety and performance in subjects who are expected to require Exteena (I.V Extension Line) & Safsite (I.V needle free connector) for attachment to I.V line with each line having a slide clamp for selective closure & use for vascular access during emergency resuscitation, Infusion therapy exchange transfusion, blood sampling, administering antibiotic, etc. Investigators and their team will be responsible for recruitment and ethical conduct of the follow-up. As per inclusion & exclusion criteria, subjects will be included in this follow-up. An Informed Consent Form/ Informed Assent Form will be obtained from all subjects who are potential follow-up candidates prior to commencement of any follow-up related procedure.

All data will be collected in the follow-up specific Case Report Form.

研究设计

研究类型: Observational

入排标准

年龄范围: 1.00 Day(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•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.

排除标准

•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.