Clinical Trial

Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence

Study acronym: MARS
Active, Not Recruiting
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Summary
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II). Data from this study will be used to support market applications and European post-market clinical follow-up needs (PMCF). The indication under investigation is reinforcement of midline laparotomy to limit the rate of incisional hernia (IH) in clean and clean-contaminated surgeries (CDC Classification I and II).
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2022-06-15; most recent amendment 2026-04-30.
Status change: Recruiting → Active, Not Recruiting 2025-05-20
Status change: Not Yet Recruiting → Recruiting 2022-11-16
Trial Details
NCT Number NCT05424484
Lead Sponsor Medtronic - MITG
Conditions Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
Enrollment 123 participants
Start Date 2022-11-22
Primary Completion 2026-04-17 (estimated)
Study Completion 2030-11 (estimated)
Updated on ClinicalTrials.gov 2026-05-06