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Swing-Mesh™ Study (SMS).

Study acronym: SMS
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Enrollment target: estimated 300 to confirmed 323
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Publications: details revised at 5 of 5 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jun 1, 2025 to Aug 30, 2025
    • Study completion date: Oct 1, 2025 to Aug 30, 2026
    • Site details revised at 2 of 2 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Secondary endpoints revised (3)
    • Study description shortened, about 409 words
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 21 words
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, prospective observational study aims to assess the safety and efficacy of the Swing-Mesh™ implant (THT BioScience™, distributed by B. Braun™, France) for laparoscopic-endoscopic inguinal hernia repair using TAPP or TEP techniques. Swing-Mesh™ is a lightweight, macroporous, three-dimensional mesh designed to conform anatomically to the myopectineal orifice without requiring fixation. Eligible adult patients undergoing elective repair will receive the implant. The primary endpoint is hernia recurrence within 6 months. Secondary endpoints include postoperative pain, groin discomfort, and early and late complications. The study will provide clinical evidence regarding the non-inferiority of this spatial, fixation-free mesh compared to standard devices in minimally invasive hernia surgery.
Trial Details
NCT Number NCT06915155
Lead Sponsor Swissmed Hospital
Conditions
(from sponsor)		 Inguinal Hernia
Related terms Hernia, Hernia, Inguinal
Enrollment 323 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov