Evaluation of SEBBIN silicone gel-filled testicular implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Gent
  Ghent, Belgium Recruiting
• Centre Hospitalier Lyon Sud
  Pierre-Bénite, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.