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

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. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/086500
Enrollment
198
Registered
2025-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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. 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1.Recurrence rate of hernia 2.Adverse Events 3. ComplicationsTimepoint: 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

MeasureTime frame
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 successTimepoint: 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—

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: Jun 11, 2026