| CTRI Number |
CTRI/2025/05/086500 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
i-Tack A (Sterile Absorbable Powered Mesh Fixation Device) |
|
Scientific Title of Study
|
A prospective, single-arm, open-label, multi-center, observational,
post-market clinical follow-up study to evaluate the safety and
performance of i-Tack A sterile absorbable powered mesh fixation
device in subjects intended for surgical mesh fixation to soft tissue in
various open or laparoscopic surgical procedures. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MES/i-Tack A_Version_1.1.0_22-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India, Valsad
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India, Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India, Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Endo-Surgery Pvt. Ltd.
Meril Park, E1-E3,
Survey No.135/2/B and 174/2,
Muktanand Marg, Chala,
Vapi – 396191, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala, Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitin Pawar |
Pawar Multispecialty Hospital |
Survey No 22, Plot 49, Balajinagar, Satara Rd, near Ellora Palace, Panchod, Dhankawadi, Pune, Maharashtra 411043
Pune
MAHARASHTRA |
9822198623
drnitinpawar@gmail.com |
| Dr Rajesh Shrivastava |
Shri Shreeji Hospital and Advance Laparoscopic Surgery Center |
Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105
Valsad
GUJARAT |
9925029477
dr.rajeshshree70@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dixit Hospital Institutional Ethics Committee |
Approved |
| Kusum Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who will undergo soft tissue minimally invasive and open general surgical and laparoscopic procedures, such as hernia repair by using i-Tack(TM) A sterile absorbable
powered mesh fixation device.
2. Subject will undergo i-Tack(TM) A sterile, absorbable,
powered mesh fixation device.
3. Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
4. Subject is not able to write on behalf of the Subject, the Subject`s LAR (Legally acceptable representative) can fill out the informed consent.
5. Adults and elderly Subjects.
6. Subject who willing and able to comply with scheduled postoperative clinical evaluations. |
|
| ExclusionCriteria |
| Details |
1.Subjects requiring extended approximation of tissues under stress.
2. Subjects with tissues that have a direct anatomic relationship to major vascular structures.
3. Subjects who underwent ischemic or necrotic tissue surgery.
4. Subjects with tissue that cannot be visually inspected for hemostasis.
5. Subjects with specific drug allergies or past comorbidities.
6. Subjects unfit for general anesthesia.
7. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Recurrence rate of hernia
2.Adverse Events
3. Complications |
1.Time Frame: 7 days ± 2 days,
15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6
months ± 30 days, 12 months ± 30 days
2. Time Frame: Discharge, 7 days ± 2 days, 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 12 months ± 30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intra-operative complications
2.Re-intervention
3.Postoperative pain
4.Length of hospital stay
5.Tack deployment accuracy
6.Wound infection
7. Mesh fixation time
8. Quality of life
9.Device success |
1.Time Frame: Intraoperative
2.Time frame: 7 days ± 2 days, 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 12 months ± 30 days
3. Time Frame: 7 days ± 2 days, 15 days ± 2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ± 30 days, 12 months ± 30 days
4. Time Frame: Admission to
discharge
5.Time Frame: Intraoperative
6. Time Frame: 7 days ± 2 days, 15 days ±
2 days, 30 days ± 7 days, 3 months ± 15 days, 6 months ±
30 days, 12 months ± 30 days
7. Time Frame: Intra-operative
8. Time Frame: Pre-operative, discharge, 7
days ± 2 days, 15 days ± 2 days, 30 days ± 7 days, 3
months ± 15 days, 6 months ± 30 days, 12 months ± 30
days
9.Time Frame: Intra-operative |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/05/2025 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: A prospective, single-arm, open-label, multi-center, observational,
post-market clinical follow-up study to evaluate the safety and
performance of i-Tack A sterile absorbable powered mesh fixation
device in subjects intended for surgical mesh fixation to soft tissue in
various open or laparoscopic surgical procedures.
Short Title i-Tack A
Protocol ID, Version
& Date: MES/i-Tack A_Version_1.0.0_12-Dec-2024
Study device: i-Tack A (Sterile Absorbable Powered Mesh Fixation Device)
Indication: i-Tack(TM) A is intended for the fixation of surgical mesh to soft tissue
in various minimally invasive and open general surgical and
laparoscopic procedures, such as hernia repair.
Objective This study aims to evaluate the safety and performance of i-Tack(TM) A.
Study Design: A prospective, single-arm, open-label, multi-center, observational,
post-market clinical follow-up study.
Study population: All the consecutive subjects will undergo fixation of surgical mesh to
soft tissue in various minimally invasive and open general surgical
and laparoscopic procedures, such as hernia repair using i-Tack(TM) A
Rationale of the Study: Mesh fixation devices are of fundamental importance in surgical outcomes. Hence, the present
study is to evaluate the safety and performance of a sterile absorbable powered mesh fixation
device composed of the delivery system and i-Tack™ A mesh fixation device in the fixation of
surgical mesh to soft tissue in various minimally invasive and open general surgical and
laparoscopic procedures, such as hernia repair
. |