Observational analysis of 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 study evaluates the short and long-term postoperative outcomes and patient satisfaction associated with silicone gel-filled testicular implants. It targets patients who require testicular prosthesis placement due to conditions such as testicular cancer, torsion, gender dysphoria, and other related issues. The study aims to gather data on complications and overall effectiveness of these implants, which have been under-researched in the literature. Participants include both adults and children who meet specific eligibility criteria and provide 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 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.

Exclusion Criteria:

* 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's running

• University Hospital Ghent
  Ghent, East-Flanders, Belgium Recruiting

Study contacts

• Principal investigator: Anne-Françoise Spinoit, MD, PhD — University Hospital, Ghent
• Study coordinator: Anne-Françoise Spinoit, MD, PhD
• Email: anne-francoise.spinoit@uzgent.be
• Phone: 003293322276

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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.