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

Study acronym: MARS
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of May 2026 to Apr 17, 2026
    • Study completion date: Sep 2028 to Nov 2030
    • Secondary endpoints: 11 to 14
    • Study description revised
    v18
  2. Re-verified, no change to tracked fieldsv17
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 123
    • Site details revised at 13 of 13 sites
    v16
  4. Primary completion date: May 2025 to May 2026
    • Start date: Nov 10, 2022 to Nov 22, 2022
    • Site contacts updated at 7 of 13 sites
    v15
  5. Study sites: 12 to 13
    • Study completion date: May 2027 to Sep 2028
    • Eligibility criteria expanded, about 83 words
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 1 of 12 sitesv13
  2. Site details revised at 1 of 12 sitesv12
  3. Site details revised at 4 of 12 sitesv11
  4. Site details revised at 2 of 12 sitesv10
  5. Study sites: 5 to 12v9
  6. Site details revised at 1 of 5 sitesv8
  7. Site details revised at 2 of 5 sitesv7
  8. Study sites: 3 to 5v6
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Nov 2022 to Nov 10, 2022
    v5
  10. Re-verified, no change to tracked fieldsv4
  11. Study sites: 0 to 1
    • Start date: Oct 2022 to Nov 2022
    v3
  12. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05424484
Lead Sponsor Medtronic - MITG
Conditions
(from sponsor)		 Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
Related terms Incisional Hernia
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov