i-Tack A (Sterile Absorbable Powered Mesh Fixation Device)

Not Applicable

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2025/05/086500

Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary: Title: A prospective, single-arm, open-label, multi-center, observational,post-market clinical follow-up study to evaluate the safety andperformance of i-Tack A sterile absorbable powered mesh fixationdevice in subjects intended for surgical mesh fixation to soft tissue invarious 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 tissuein various minimally invasive and open general surgical andlaparoscopic 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 tosoft tissue in various minimally invasive and open general surgicaland 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 presentstudy is to evaluate the safety and performance of a sterile absorbable powered mesh fixationdevice composed of the delivery system and i-Tack™ A mesh fixation device in the fixation ofsurgical mesh to soft tissue in various minimally invasive and open general surgical andlaparoscopic procedures, such as hernia repair

.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 198

Inclusion Criteria

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.
Subject will undergo i-Tack(TM) A sterile, absorbable, powered mesh fixation device.
Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
Subject is not able to write on behalf of the Subject, the Subject`s LAR (Legally acceptable representative) can fill out the informed consent.
Adults and elderly Subjects.
Subject who willing and able to comply with scheduled postoperative clinical evaluations.

Exclusion Criteria

1.Subjects requiring extended approximation of tissues under stress.
Subjects with tissues that have a direct anatomic relationship to major vascular structures.
Subjects who underwent ischemic or necrotic tissue surgery.
Subjects with tissue that cannot be visually inspected for hemostasis.
Subjects with specific drug allergies or past comorbidities.
Subjects unfit for general anesthesia.
Pregnant women.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Recurrence rate of hernia	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
2.Adverse Events	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
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 Measures

Name	Time	Method
1.Intra-operative complications	2.Re-intervention

Trial Locations

Locations (1): Shri Shreeji Hospital and Advance Laparoscopic Surgery Center
🇮🇳
Valsad, GUJARAT, India
Shri Shreeji Hospital and Advance Laparoscopic Surgery Center
🇮🇳Valsad, GUJARAT, India
Dr Rajesh Shrivastava
Principal investigator
9925029477
dr.rajeshshree70@gmail.com