A prospective, single-arm, post-market clinical follow-up of Bi-Valve (Three-way stop cock) to explore safety and performance in Indian population.

Romsons Scientific and Surgical Industries Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1.Males and Females above 18 years who are expected to require simultaneous infusions, intermittent drug injections, blood samplings, central venous pressure measurements, arterial add-on devices used for invasive pressure measurements, blood sampling/s, flushing with normal saline, etc.
•2.Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process.
•3.The subject is willing and able to comply with the requirement of the follow-up.

•1.Subject who present with medical emergency, where treatment is more priority than the informed consent process.
•2.Any planned therapy of corrosive medications, photosensitive medication and highly viscous fluids.
•3.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.
•4.Any known allergy of material of Three-way stop cock and its component.
•5.Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the 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.

发起方

Romsons Scientific and Surgical Industries Pvt Ltd