Swing-Mesh™ Study (SMS). (SMS)

December 4, 2025 updated by: Swissmed Hospital

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic techniques such as TAPP and TEP are currently recommended as the standard approach for inguinal hernia repair due to faster recovery, reduced postoperative pain, and lower complication rates compared to open surgery.

To address the limitations of flat meshes in minimally invasive procedures, three-dimensional implants have been developed. These are better suited to the anatomical structure of the myopectineal orifice (MPO), reducing the risk of mesh migration without the need for fixation.

Swing-Mesh™ is a new lightweight, macroporous 3D implant introduced to the Polish market in 2025. Its structure is based on thermally modified polypropylene fibers, eliminating the need for rigid stabilizing rings. The implant is suitable for both right- and left-sided hernias.

The aim of this study is to assess the safety and clinical performance of Swing-Mesh™ in real-world settings. The primary endpoint is the hernia recurrence rate within 6 months. Secondary outcomes include postoperative pain, early and late complications, and patient-reported groin discomfort.

This is a prospective, multicenter, observational cohort study. Consecutive patients undergoing elective laparoscopic inguinal hernia repair will be enrolled after providing informed consent. The Swing-Mesh™ (15×11 cm or 16×12 cm) will be implanted without fixation. Selected surgical steps will be documented (photo/video), anonymized, and stored on a secure research platform.

Follow-up will be conducted at 7-10 days, 30 days, 3 months, and 6 months postoperatively. Data will be collected via structured telephone interviews or in-person visits, as needed.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-280
        • Swissmed Hospital
    • Gdańsk
      • Gdansk, Gdańsk, Poland, 80-215
        • Swissmed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective laparoscopic-endoscopic inguinal hernia repair using the Swing-Mesh™ implant. The study population includes adult patients of both sexes who meet the inclusion criteria and do not have any of the specified exclusion criteria. Participants will be recruited from surgical centers in Poland.

Description

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 <18 years
  • emergency surgery (incarcerated hernia)
  • contaminated surgical field
  • recurrent hernia
  • extremely large scrotal hernias with the need of other abdominal compartment syndrome (ACS) preventive procedures (botulin injection, bowel resection, preoperative progressive pneumoperitoneum - PPP)
  • M3 or M3+L1-3 (EHS classification) groin hernia confirmed during surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: Swing-Mesh™
A lightweight, macroporous, three-dimensional polypropylene mesh implant developed by THT BioScience™ and distributed by B. Braun™, used in laparoscopic-endoscopic inguinal hernia repair without fixation. The mesh is designed to conform to the anatomical shape of the myopectineal orifice and is available in two sizes (15×11 cm or 16×12 cm).
Other Names:
  • THT BioScience mesh, 3D hernia mesh, SwingMesh, B. Braun mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia recurrence rate within 6 months
Time Frame: 6 months post-surgery
Incidence of clinically or radiologically confirmed inguinal hernia recurrence during a 6-month follow-up period. Expected recurrence rate: 2-4%.
6 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early and late postoperative complications
Time Frame: Up to 6 months post-surgery
Assessment of complications such as wound infection, hematoma, and seroma within 30 days (early) and up to 6 months (late).
Up to 6 months post-surgery
Groin discomfort and foreign body sensation
Time Frame: 7-10 days, 30 days, 3 months, and 6 months post-surgery
Patient-reported outcomes regarding groin discomfort and sensation of a foreign body during scheduled follow-up interviews.
7-10 days, 30 days, 3 months, and 6 months post-surgery
Postoperative pain intensity (Visual Analog Scale 0-10)
Time Frame: 7-10 days, 30 days, 3 months, and 6 months post-surgery
Evaluation of postoperative pain using the Visual Analog Scale (VAS) at specified time points. Chronic pain defined as pain ≥4/10 persisting beyond 3 months.
7-10 days, 30 days, 3 months, and 6 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swissmed Hospital

Investigators

  • Study Chair: Mateusz Zamkowski, MD, PhD, Swissmed Hospital
  • Study Director: Maciej Śmietański, prof., Swissmed Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Actual)

August 30, 2025

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (e.g., recurrence outcomes, VAS scores) may be shared upon reasonable request, after publication of the study results.

IPD Sharing Time Frame

After completion of the study and publication of results

IPD Sharing Access Criteria

Requests must be made by qualified researchers with a methodologically sound proposal, subject to approval by the study investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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