Evaluation of SEBBIN silicone gel-filled testicular implants
Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants
This study is testing how safe and effective SEBBIN silicone gel-filled testicular implants are for both adults and children who need them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Groupe SEBBIN Industry-sponsored |
| Locations | 2 sites (Ghent and 1 other locations) |
| Trial ID | NCT04968470 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of SEBBIN silicone gel-filled testicular implants. It aims to gather additional data on the durability and complications associated with these implants. Participants include both adults and children who are candidates for unilateral or bilateral testicular implant placement. The study involves collecting information from patients who have received the SEBBIN implant and have provided informed consent.
Who should consider this trial
Good fit: Ideal candidates are adults or children who are undergoing unilateral or bilateral testicular implant placement with SEBBIN implants.
Not a fit: Patients with silicone implants in areas other than the scrotal sac or those with certain autoimmune or inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and longevity of SEBBIN testicular implants, leading to improved patient outcomes.
How similar studies have performed: While this study focuses on a specific brand of implants, similar studies evaluating the safety and effectiveness of testicular implants have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient is an adult or a child at the time of implant placement with SEBBIN implant. * The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant. * The patient has been informed of the study, has read the patient information letter and -provided oral consent. Exclusion Criteria: * The patient has silicone implants somewhere else than in the scrotal sac. * The patient was diagnosed with one of the following pathologies: * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease. * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease. * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease. * The patient has a pathology that could delay healing. * Custom-designed implants are used for surgery.
Where this trial is running
Ghent and 1 other locations
- UZ Gent — Ghent, Belgium (Recruiting)
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.