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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- The primary objective of this study is to evaluate safety associated with epidural catheter in patients requiring epidural anesthesia or analgesia during routine clinical practice.
研究概览
简要总结
A prospective,open label, multi-centre, single arm, observational, post marketing clinicalfollow-up study to evaluate safety and clinical performance of epiduralcatheter in patients requiring epidural anesthesia or analgesia during routineclinical practice.
Primary objective: The primaryobjective of this study is to evaluate safety associated with epidural catheterin patients requiring epidural anesthesia or analgesia during routine clinicalpractice.
Secondary objective: The secondaryobjective is to evaluate clinical performance of the epidural catheter inpatients requiring epidural anesthesia or analgesia during routine clinicalpractice.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The primary objective of this study is to evaluate safety associated with epidural catheter in patients requiring epidural anesthesia or analgesia during routine clinical practice.
时间窗: During Index procedure, Day - 1. Week 1 plus or minus 1 day.
次要结局
- The secondary objective is to evaluate clinical performance of the epidural catheter in patients requiring epidural anesthesia or analgesia during routine clinical practice.(During Index procedure, Day 1)