A prospective, single arm, multi-centric, post market clinical follow-up of Spinal Needle to explore its safety and performance in Adult, Pregnant & 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5月27日

试验速览

暂无简介。

•1.Males and Females (including the Pregnant Females), along with the Paediatric subjects who are expected to require transient anesthesia/ analgesia by spinal puncture for surgeries demanding regional nerve-block or to facilitate Cerebro Spinal Fluid (CSF) sampling.
•2.Subject who can provide Informed Consent Form (Adult) in writing and medically in a position to undergo consenting and screening process.
•3.In case of Pregnant Female, the pregnant female need to provide Informed Consent Form (Pregnant Female) duly signed by herself as well as her Partner.
•4.In case of Paediatric subjects, parent of child / LAR (Legally Acceptable Representative) can provide Informed Assent Form (Child) or give permission.
•5.Subject who is willing and able to comply with the requirement of the follow-up.
•6.In case of Paediatric subjects, parent of child / LAR (Legally Acceptable Representative) who is willing and able to comply with the requirement of the follow-up.
•7.In case of Pregnant Female, the pregnant female and / or her Partner 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) such as unconscious, mentally challenged patient, etc.
•3.In case of Pregnant Female, the pregnant female or her partner cannot provide Informed Consent Form (Pregnant Female) for her, etc.
•4.In case of Paediatric subjects, parent of child / LAR (Legally Acceptable Representative) who cannot provide Informed Assent Form (Child) or give permission, etc.
•5.Any known allergy with any of the material of the device Spinal Needle and/or its component(s).
•6.Other conditions, which in the opinion of investigators make the patient unsuitable for enrolment or could, interfere with his / her participation and in completion of the protocol.
•7.Participation in another research study involving an active investigation within 30 days prior to consent.

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