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Completed NCT06915155

Swing-Mesh™ Study (SMS).

Conditions: Inguinal Hernia

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 323
Sponsor: Swissmed Hospital

Location: Swissmed Hospital Gdansk Gdańsk

Summary

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.

Eligibility Criteria

Inclusion Criteria: * elective groin hernia repair * age \> 18 years * male and female patients can participate * eligibility for laparoendoscopic repair * signed written informed consent Exclusion Criteria: * age \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06915155). StuddyBuddy aggregates publicly available trial information.