i-Tack N POWERED MESH FIXATION

A prospective, single-arm, open-label, multi-center, observational, post-marketing clinical follow-up 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. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/04/085602

Enrollment

100

Registered

2025-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

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. 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Re-occurrence rate of hernia 2.Complications Timepoint: 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

Measure	Time frame
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 lifeTimepoint: 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	—

Measure

Time frame

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 lifeTimepoint: 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

—

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026