i-Tack N POWERED MESH FIXATION

Not Applicable

Not yet recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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.
The subject must be an adult age group, and both men and women are included in the study.
The Subjects should be treated with i-Tack™ N.
The Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
A minimum of 4 mm thickness of tissue over underlying bone, vessels, or viscera is required for applying i-Tack™ N.

Exclusion Criteria

i-Tack™ N is not recommended where an extended approximation of tissues under stress is required.
i-Tack™ N should not be used in tissues that have a direct anatomic relationship to major vascular structures.
i-Tack™ N should not be used in Subjects who underwent ischemic or necrotic tissue surgery.
i-Tack™ N should not be used in Subjects whose tissue cannot be inspected visually for hemostasis.
Subjects (female) who are pregnant or actively breast feeding.
Subjects with specific drug allergies or past comorbidities 7.
Subjects with a complicated hernia and Subject unfit for general anesthesia.

Primary Outcome Measures

Name	Time	Method
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
1.Re-occurrence rate of hernia	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 Measures

Name	Time	Method
1.Re-occurrence rate of hernia	2.Post-operative pain

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