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Active, Not Recruiting

NCT Number: NCT06915155

Swing-Mesh™ Study (SMS).

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Swissmed Hospital, Gdansk, Gdańsk, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swing-Mesh™

Device

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

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Swissmed Hospital

Other

Registry information

Official study title

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.

Acronym: SMS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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