Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Launched by UNIVERSITY HOSPITAL, GHENT · Oct 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of silicone gel-filled testicular implants, which are used for a variety of conditions such as testicular cancer, testicular torsion, and gender dysphoria. The goal is to evaluate how these implants perform both shortly after surgery and in the long term, focusing on how satisfied patients are with the results. The trial is currently recruiting participants of all ages, from newborns to adults, who need one or two implants and have given their consent to join the study.

To be eligible, patients must be either adults or children who are set to receive a testicular implant. They should not have silicone implants in other parts of their body (except for specific penile implants), and certain medical conditions that could affect healing will exclude them from the study. Participants can expect to have their experiences and outcomes monitored post-surgery, helping researchers understand the effectiveness and durability of these implants over time. If you or someone you know is considering this type of surgery, this trial could provide valuable information about potential outcomes and patient satisfaction.

Gender

ALL

Eligibility 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.