A Prospective, Open Label, Multi-Center, Single Arm, Observational, Post Marketing Clinical Follow-Up Study to Evaluate Safety and Clinical Performance of Medispine/Glospine Spinal Needle in Patients who Required Spinal Anesthesia. - NA

Global Medikit Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Patient aged greater of equal to 18 years at the time of enrolment
•2. Patient or his/her legally authorized representative (LAR) (if applicable) agrees to provide written informed consent
•3. Patient is willing to comply with clinical investigation plan (CIP) specified follow-up evaluations
•4. In case of anesthetic procedure carried out for hip or lower extremity surgeries, patients with American Society of Anaesthesiologists (ASA) physical status I-III who are planned to undergo surgery with spinal anesthesia.

•1. Patients with contraindications for spinal anesthesia and lumbar puncture mentioned in the study devices Instructions For Use (IFU)
•2. Prior sacral or lumbar spine surgery
•3. History of migraines or chronic headaches or previous PDPH
•4. History of neurological deficits
•5. Severe hypovolemia
•6. Agitation or delirium, impaired cognition or dementia
•7. Currently participating in another clinical study with experimental drugs or devices
•8. Active SARS-CoV-2 infection known to patient at the time of enrolment in the study or patients having signs and symptoms of SARS-Co V-2 infection at the time of enrolment

发起方

Global Medikit Ltd