Epidural Catheter PMCF study: A Prospective, Open Label, Multi-Centre, Single Arm, Observational, Post Marketing Clinical Follow-Up Study to Evaluate Safety and Clinical Performance of Epidural Catheter in Patients Requiring Epidural Anesthesia or Analgesia During Routine Clinical Practice. - NA

Global Medikit Limited0 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

试验速览

暂无简介。

•1.Patient aged greater than or equal to 18 to less than or equal to 75 years at the time of enrolment.
•2.Patient who receive epidural anesthesia/analgesia or post-surgery analgesia using epidural catheter (from Epidural Mini-pack Kit) by the investigator/treating physician during routine clinical practice.
•3.Patients with American Society of Anaesthesiologists (ASA) physical status I-III.
•4.Patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent.
•5.Patient is willing to comply with clinical investigation plan (CIP) specified follow-up evaluations.

•1.Patient with contraindications for epidural anesthesia mentioned in the IFU or patients undergoing unscheduled/emergency surgeries
•2.Anatomical deformities/wound/scar at puncture site
•3.Localized infection at puncture site, or general infection (septicaemia)
•4.Hypersensitive or allergic to local anaesthesia and/or any material used for that purpose
•5.Currently participating in another clinical study with experimental drugs or devices
•6.Active SARS-CoV-2 infection known to patient at the time of enrolment in the study/ patients having signs and symptoms of SARS-CoV-2 infection at the time of enrolment

发起方