Tundra Space

Tundra Space

Book DemoDirectoryLog InSign Up

Clinical Research Directory

Browse clinical research sites, groups, and studies.

SitesGroupsStudies
Back to Studies
NOT YET RECRUITING
NCT07836179

Safety and Effectiveness of Optomesh 3D for Inguinal Hernia Repair

Sponsor: Swissmed Hospital

View on ClinicalTrials.gov

Summary

OPTIMUS is an observational study assessing the safety and effectiveness of Optomesh 3D, a shaped surgical mesh used in planned keyhole surgery for a groin (inguinal) hernia. The mesh is placed without additional stitches, tacks, or glue to hold it in position. The study aims to include at least 300 patients from several hospitals. The main question is how often a hernia returns within 12 months after surgery. Researchers will also assess pain, postoperative complications, discomfort in the groin, and the feeling of having a foreign material in the operated area. Participants will provide written consent for the study. Information about their health and operation will be recorded. Follow-up information will be collected through telephone interviews at 7-10 days, 30 days, 3 months, and 12 months after surgery. The results will be assessed in relation to previously published findings on hernia repair.

Official title: Safety and Efficacy of the Optomesh® 3D Implant (TZMO S.A., Poland) in Laparoscopic-Endoscopic Inguinal Hernia Repair - A Multicenter, Prospective Observational Study (OPTIMUS Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2026-11-01

Completion Date

2028-02-01

Last Updated

2026-09-23

Healthy Volunteers

No

Conditions

Inguinal Hernia

Interventions

DEVICE

Optomesh 3D

Optomesh 3D (TZMO S.A., Poland) is an anatomically shaped, non-absorbable polypropylene mesh used for inguinal hernia repair. The implant is available in right-sided and left-sided variants and in S/M and L sizes. The mesh is placed in the preperitoneal space during TAPP or TEP repair without additional fixation using sutures, tacks, or glue. The implant variant and size are selected according to the patient's anatomy. Outcomes following mesh implantation are recorded prospectively in this observational study.

Locations (1)

LUX MED Szpital Gdańsk

Gdansk, Poland