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CTRI Number  CTRI/2021/10/037328 [Registered on: 14/10/2021] Trial Registered Prospectively
Last Modified On: 13/10/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Study to Evaluate Safety and Clinical Performance of Epidural Catheter in Patients Requiring Epidural Anesthesia or Analgesia During Routine Clinical Practice. 
Scientific Title of Study   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. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
EUP-GML-21-002, Version 1.0 dated 24-Jun-2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jatin Soni 
Designation  Head- Clinical Operations & Project Management 
Affiliation  Eupraxia Centre For Clinical Excellence LLP 
Address  205, Spentha Complex, Race Course, Opposite Pizza Hut, Vadodara-390007, Gujarat, India

Vadodara
GUJARAT
390007
India 
Phone  9630635333  
Fax    
Email  jsoni@eupraxiaconsulting.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jatin Soni 
Designation  Head- Clinical Operations & Project Management 
Affiliation  Eupraxia Centre For Clinical Excellence LLP 
Address  205, Spentha Complex, Race Course, Opposite Pizza Hut, Vadodara-390007, Gujarat, India


GUJARAT
390007
India 
Phone  9630635333  
Fax    
Email  jsoni@eupraxiaconsulting.com  
 
Details of Contact Person
Public Query  
Name  Dr Jatin Soni 
Designation  Head- Clinical Operations & Project Management 
Affiliation  Eupraxia Centre For Clinical Excellence LLP 
Address  205, Spentha Complex, Race Course, Opposite Pizza Hut, Vadodara-390007, Gujarat, India


GUJARAT
390007
India 
Phone  9630635333  
Fax    
Email  jsoni@eupraxiaconsulting.com  
 
Source of Monetary or Material Support  
Global Medikit Limited Dr. G.C. Narang Marg, Cavalry Rd, New Delhi – 110 007, India  
 
Primary Sponsor  
Name  Global Medikit Limited 
Address  Dr. G.C. Narang Marg, Cavalry Rd, New Delhi – 110 007, India  
Type of Sponsor  Other [Medical device manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Preeti Amrish Nanda  BAJ RR Hospital  P-14, Phase-I,Milap Nagar, Dombivli(E) Dist.Thane, Maharashtra-421203, india
Thane
MAHARASHTRA 		 9820576741

nandadrpreeti@gmail.com 
Dr Ashpak Bangi  Jivanrekha Multispecialty Hospital  Sr.28, Prabhu Complex, Old Mumbai - Pune Hwy, opposite to Republic School, Pune, Maharashtra 412101, India
Pune
MAHARASHTRA 		 7972700600

drashpakresearch@gmail.com 
Dr Sonia Naik  Shree Ashirwad Hospital  C/3 Shree complex, Opposite Mahavir Nagar, Manpada Road Dombivali(E) 421201, Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA 		 9930480526

naik.sonia2002@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Altezza Institutional Ethics Committee  Submittted/Under Review 
Altezza Institutional Ethics Committee  Submittted/Under Review 
Jivanrekha Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Epidural catheter (from Epidural Mini-pack Kit)  Dose:NA, Frequency: NA, Duration of Therapy: Standard of Care  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.   During Index procedure, Day - 1. Week 1 plus or minus 1 day. 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 

Primary objective: 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.

Secondary objective: The secondary objective is to evaluate clinical performance of the epidural catheter in patients requiring epidural anesthesia or analgesia during routine clinical practice.

 
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