Safety and Efficacy of the Swing-Mesh™ Implant (THT BioScience™, B. Braun™, France) in Laparoscopic-endoscopic Inguinal Hernia Repair - a Multicenter, Cohort, Prospective Observational Study.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• elective groin hernia repair

• age \> 18 years

• male and female patients can participate

• eligibility for laparoendoscopic repair

• signed written informed consent

Locations
Other Locations
Poland
Swissmed Hospital
RECRUITING
Gdansk
Swissmed Hospital
RECRUITING
Gdansk
Contact Information
Primary
Mateusz Zamkowski, MD, PhD
zamek@gumed.edu.pl
504236036
Backup
Magdalena Halska
worldofsurge@gmail.com
607870690
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 300
Treatments
Swing-Mesh™ Cohort
Patients undergoing elective laparoscopic-endoscopic inguinal hernia repair (TAPP or TEP) using the Swing-Mesh™ implant without fixation. Follow-up is conducted at 7-10 days, 30 days, 3 months, and 6 months to assess recurrence, pain, complications, and groin discomfort.
Related Therapeutic Areas
Sponsors
Leads: Swissmed Hospital

This content was sourced from clinicaltrials.gov