| CTRI Number |
CTRI/2025/04/085602 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
i-Tack N POWERED MESH FIXATION |
|
Scientific Title of Study
|
A prospective, single-arm, open-label, multi-center, observational, Post-Marketing Clinical Surveillance Study to evaluate the safety and performance of i-Tack(TM) N in subject intended for surgical mesh fixation to soft tissue in various open or laparoscopic surgical procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MES/i-Tack N POWERED MESH FIXATION V1.0.0 dated 12-Dec-2024 |
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
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Shrivastava |
Shri Shreeji Hospital and Advance Laparoscopic Surgery Center |
Ground floor, Genral Sugeries, Bhilad Sanjan Road, Daheli, Tal, Umargam, Gujarat 396105
Valsad
GUJARAT |
9925029477
dr.rajeshshree70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dixit Hospital Institutional 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.All consecutive Subjects who will underwent surgical experience like soft tissue in various minimally invasive and open general surgical and laparoscopic procedures, such as hernia repair.
2. The subject must be an adult age group, and both men and women are included in the study.
3. The Subjects should be treated with i-Tack™ N.
4. The Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
5. A minimum of 4 mm thickness of tissue over underlying bone, vessels, or viscera is required for applying i-Tack™ N. |
|
| ExclusionCriteria |
| Details |
1. i-Tack™ N is not recommended where an extended approximation of tissues under stress is required.
2. i-Tack™ N should not be used in tissues that have a direct anatomic relationship to major vascular structures.
3. i-Tack™ N should not be used in Subjects who underwent ischemic or necrotic tissue surgery.
4. i-Tack™ N should not be used in Subjects whose tissue cannot be inspected visually for hemostasis.
5. Subjects (female) who are pregnant or actively breast feeding.
6. Subjects with specific drug allergies or past comorbidities
7. Subjects with a complicated hernia and Subject unfit for general anesthesia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Re-occurrence rate of hernia
2.Complications
|
1.Time Frame: 7 days ± 2 days, 6 months ± 30 days
2.Time Frame: Intra-operative, 7 days ± 2 days, 30 days ± 5 days, 3 months ± 15 days, 6 months ± 30 days, 1 year± 30 days, 3 year± 30 days and 5 year± 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Re-occurrence rate of hernia
2.Post-operative pain
3.Operation time
4.Time for mesh fixation
5.Post-operative Assessment of Mesh Fixation
6.Length of hospital stay
7.Quality of life |
1.Time Frame: 1 year± 30 days, 3 year± 30 days and 5 year± 30 days
2.Time Frame: 7 days ± 2 days, 30 days ± 5 days, 3 months ± 15 days, 6 months ± 30 days, 1 year± 30 days, 3 year± 30 days and 5 year ± 30 days
3.Time Frame: Intra-operative
4.Time Frame: Intra-operative
5.Time Frame: Discharge, 7 days ± 2 days, 30 days ± 5 days, 3 months ± 15
days, 6 months ± 30 days, 1 year± 30 days, 3 year± 30 days and 5 year ± 30 days
6. Time Frame: From Admission to Discharge
7.Time Frame: 30 days ± 5 days, 3 months ± 15 days, 6 months ± 30 days, 1 year ± 30 days, 3 year± 30 days and 5 year ± 30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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="5"
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- Marketing Clinical Surveillance Study to evaluate the safety and performance of i- Tack™ N in subject intended for surgical mesh fixation to soft tissue in various open or laparoscopic surgical procedures.
Short Title: i-Tack N POWERED MESH FIXATION
Protocol ID, Version & Date: i-Tack N POWERED MESH FIXATION_Version_1.0.0_12-Dec-2024
Study device: i-Tack(TM) N (Sterile Non-absorbable Powered Mesh Fixation Device)
Indication: i-Tack(TM) N 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) N
Study Design: A prospective, single-arm, open-label, multi-center, observational, Post Marketing Clinical Surveillance Study.
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, non-absorbable powered mesh fixation device composed of the delivery system and titanium spikes (i-Tack™ N 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. The device is sterilized by ethylene oxide. |