SEBBIN Silicone Gel-filled Testicular Implants

Launched by GROUPE SEBBIN · Jul 19, 2021

Keywords

ClinConnect Summary

The SEBBIN Silicone Gel-filled Testicular Implants trial is studying the safety and effectiveness of a specific type of testicular implant. This research aims to gather more information about how well these implants work and if they are safe for patients. The study is currently looking for participants, including both adults and children, who are candidates for one or two testicular implants using SEBBIN devices. To participate, individuals need to have been informed about the study and provide their consent.

Participants in this trial can expect to receive the SEBBIN implant and will be monitored for its performance and any potential complications. However, not everyone can join the study. For instance, individuals with certain autoimmune diseases, existing silicone implants in other parts of the body, or specific conditions that could slow down healing will not be eligible. This research is important for ensuring that the implants are safe and effective for those who need them.

Gender

ALL

Eligibility criteria

• 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.