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Safety and Efficacy of the 3DMax™ MID Anatomical Mesh (BD, USA) in Laparoscopic-endoscopic Inguinal Hernia Repair

Study acronym: 3DMS
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Show 6 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 1, 2026 to Feb 1, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Publications: details revised at 4 of 4 entries
    • Study title shortened, about 5 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, prospective, observational cohort study evaluating the safety and efficacy of the 3DMax MID Anatomical Mesh (BD, USA) in laparoendoscopic inguinal hernia repair. Adult patients undergoing elective transabdominal preperitoneal (TAPP) or totally extraperitoneal (TEP) repair will be enrolled and followed according to routine clinical practice. The primary objective is to assess the inguinal hernia recurrence rate within 12 months after surgery. Secondary objectives include evaluation of postoperative pain, groin discomfort and foreign body sensation, as well as early and late postoperative complications. All participating patients will receive the 3DMax MID Anatomical Mesh as part of standard care. No additional experimental procedures are planned. Clinical data will be collected at baseline and during predefined follow-up contacts (early postoperative period, 1 month, 3 months and 12 months) using standardized forms and patient interviews.
Trial Details
NCT Number NCT07289802
Lead Sponsor Swissmed Hospital
Conditions
(from sponsor)		 Hernia, Inguinal
Related terms Hernia, Hernia, Inguinal, Recurrence
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov