SEBBIN Silicone Gel-filled Testicular Implants
Recruiting
- Conditions
- ComplicationProsthesis Durability
- Registration Number
- NCT04968470
- Lead Sponsor
- Groupe SEBBIN
- Brief Summary
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complication rate At 10 years of follow-up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
UZ Gent
🇧🇪Gent, Belgium