Actively Recruiting
SEBBIN Silicone Gel-filled Testicular Implants
Led by Groupe SEBBIN · Updated on 2024-10-31
100
Participants Needed
2
Research Sites
754 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SEBBIN Silicone Gel-filled Testicular Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- The patient has silicone implants somewhere else than in the scrotal sac.
- The patient was diagnosed with systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
- The patient was diagnosed with rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
- The patient was diagnosed with 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
2
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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