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CTRI Number  CTRI/2023/05/052531 [Registered on: 11/05/2023] Trial Registered Prospectively
Last Modified On: 19/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess metal clips usage in laparoscopic gall bladder removal surgery 
Scientific Title of Study   A Prospective, Single-blind, Randomized, Multi centre, study to assess the clinical equivalence of Trutie® Ligating clips to Ligaclip® ligating clips in laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IND-HEALTHIUM-TRUTIE-2023-16, Version -1, 27 February 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Kumar Moharana  
Designation  Chief Medical Officer  
Affiliation  Healthium Medtech Limited  
Address  Healthium Medtech 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya, Bengaluru, Karnataka

Bangalore
KARNATAKA
560058
India 
Phone  9717887751   
Fax    
Email  ashok.m@healthiummedtech.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kumar Moharana  
Designation  Chief Medical Officer  
Affiliation  Healthium Medtech Limited  
Address  Healthium Medtech 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya, Bengaluru, Karnataka


KARNATAKA
560058
India 
Phone  9717887751   
Fax    
Email  ashok.m@healthiummedtech.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashok Kumar Moharana  
Designation  Chief Medical Officer  
Affiliation  Healthium Medtech Limited  
Address  Healthium Medtech 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya, Bengaluru, Karnataka


KARNATAKA
560058
India 
Phone  9717887751   
Fax    
Email  ashok.m@healthiummedtech.com  
 
Source of Monetary or Material Support  
Healthium Medtech 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya, Bengaluru, Karnataka 560058 
 
Primary Sponsor  
Name  Healthium Medtech Limited  
Address  Healthium Medtech 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Peenya, Bengaluru, Karnataka 560058 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Srikanth Kulkarni  BGS Global Institute of Medical Sciences  Ground Floor OPD, No 67 BGS Health and Education City Uttarahalli Road Kengeri
Bangalore
KARNATAKA 
9980218989

drsrikanthbgsresearch@gmail.com 
Dr Sanjay Kala  GSVM Medical college  Principal Room Department of General Surgery Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH 
9939210012

surgerygsvmmc@gmail.com 
Dr Seraj Ahmed  Institute of Post Graduate Medical Education and Research and SSKM Hospital  Ronald Ross Building, 6th Floor, Department of General Surgery, 244 AJC Bose Road
Kolkata
WEST BENGAL 
9830425786

seraj1211@gmail.com 
Dr Prashant V Rahate  Seven Star Hospital  OPD no 4, Ground Floor, Jagnade Square, Great Nag Road, Nandanwan
Nagpur
MAHARASHTRA 
9822464068

prashantrahate84@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College Kanpur  Approved 
Ethics Committee Rahate Surgical Hospital  Approved 
Institutional Ethics Committee   Approved 
IPGME and R Resaerch Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LIGACLIP Ligating clips  Ligaclip ligating clips are used for ligation of tubular structure or vessels where a non-absorbable ligating clip is indicated. Once applied will not be removed from the body.  
Intervention  TRUTIE Ligating clips  Trutie ligating clips are used for ligation of tubular structure or vessels where a non-absorbable ligating clip is indicated. Once applied will not be removed from the body.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male or Female patients aged between 18 to 60 years
2. Subjects scheduled for elective laparoscopic cholecystectomy surgery
3. Subjects willing to give written informed consent and willing to comply with all study requirements 
 
ExclusionCriteria 
Details  1. Subjects with history of pancreatitis
2. Subjects with suspicion of gallbladder carcinoma or other metastatic diseases
3. Subjects who are pregnant or lactating at the time of surgery
4. Subjects with coagulation disorder
5. Subjects intraoperatively found to have with modified Nassar difficulty grading scale 3 4 and 5
6. Subjects whose surgical approach got converted from laparoscopic to open surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assess the incidence of bile leakage and bleeding after closure of cystic duct and cystic artery in both groups  Day of surgery, Day of discharge, Day 10 post surgery, Day 30 post surgery, Day 180 post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of intra and post operative complications adverse device reactions and adverse events from day of surgery to 6 months post operatively  Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery 
Time taken from initial incision to closure of wound
 
Day of surgery 
Number of clips used to ligate cystic duct and artery  Day of surgery 
Assessment of intraoperative handling of clips between the two groups using 5 point scale and Assessment of number of clip breakage failure to ligate and malformed or deformed clips  Day of surgery 
Postoperative length of hospital stay in both the groups  Day of discharge 
To assess the incidence of residual risks of ligating clips  Day of surgery Day of discharge Day 10 post surgery Day 30 post surgery Day 180 post surgery 
To assess the time to recovery as measured by return to the normal day to day activities  Day 10 post surgery Day 30 post surgery Day 180 post surgery 
To evaluate the quality of life using the Otago gallstones condition specific questionnaire  Baseline visit Day 30 post surgery Day 180 post surgery 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/05/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The current study aims to establish clinical equivalence of Trutie® Ligating clips (Healthium Medtech Limited) to Ligaclip® ligating clips (Ethicon) in laparoscopic cholecystectomy and generate additional evidence on usage of Titanium metal ligating clips. The use of surgical clips is crucial in laparoscopic surgery/ cholecystectomy. Titanium ligating clips are a type of non-absorbable clip that are commonly used in laparoscopic cholecystectomy procedures to secure the cystic duct and cystic artery during gallbladder removal. These clips are made of a lightweight, durable metal and are designed to provide a secure and permanent closure of the ducts. In current study we plan to assess the clinical equivalence of both devices via incidence of bile leakage and bleeding after closure of cystic duct and cystic artery, assessment of intra and post-operative complications, adverse device reactions, and adverse events from day of surgery to 6 months post-operatively, time taken from initial incision to closure of wound, intraoperative handling of clips and clip applicator between the two groups using 5-point scale, number of clip breakage, failure to ligate, and malformed or deformed clips, Postoperative length of hospital stay, incidence of residual risks of ligating clips, time to recovery as measured by return to the normal day to day activities and quality of life using the Otago gallstones condition specific questionnaire. Clinical data obtained by this study will add value to the user’s decision to choose the titanium ligating clip in various surgeries.

 
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