Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
Recruiting now
Conditions studied: Testicular Cancer, Testicular Torsion, Gender Dysphoria, Undescended Testes, Orchitis, Testicular Agenesis, Testicular Atrophy, Prosthesis Durability
In brief
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
Key facts
- Study ID
- NCT05097820
- Run by
- University Hospital, Ghent
- People needed
- 100
- Starts
- 2021-02-05
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2024-09-19
Who can join
Age: any, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The patient is an adult or a child at the time of testicular implant placement.
- The patient is a candidate to unilateral or bilateral testicular implant placement.
- The patient has been informed of the study, has read the patient information letter and provided oral and written consent.
- If the patient is of French nationality, he/she must be affiliated to the French Social Security.
You may not qualify if…
- The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).
- 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 any other underlying condition that could delay healing.
- Custom-designed implants are used for surgery.
Where it is running
- University Hospital Ghent — Ghent, East-Flanders, Belgium (enrolling)
Full record on ClinicalTrials.gov
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