Observational analysis of silicone gel-filled testicular implants
Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
This study is trying to see how well silicone gel-filled testicular implants work and how satisfied patients are after getting them, for people who need these implants due to various medical conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Years to 110 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, East-Flanders) |
| Trial ID | NCT05097820 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults and children who are undergoing unilateral or bilateral testicular implant placement due to various medical conditions.
Not a fit: Patients with existing silicone implants outside of the scrotal sac or those with certain autoimmune or inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of patient satisfaction and outcomes related to testicular implants, leading to better clinical practices.
How similar studies have performed: While there is limited literature on the specific SEBBIN silicone gel-filled implants, similar studies on testicular prostheses have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ghent, East-Flanders
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.