NCT04968470 SEBBIN Silicone Gel-filled Testicular Implants
| NCT ID | NCT04968470 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe SEBBIN |
| Condition | Complication |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-03-16 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-03-16 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.
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.
Frequently Asked Questions
Who can join the NCT04968470 clinical trial?
This trial is open to participants of all sexes, studying Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04968470 currently recruiting?
Yes, NCT04968470 is actively recruiting participants. Visit ClinicalTrials.gov or contact Groupe SEBBIN to inquire about joining.
Where is the NCT04968470 trial being conducted?
This trial is being conducted at Ghent, Belgium, Pierre-Bénite, France.
Who is sponsoring the NCT04968470 clinical trial?
NCT04968470 is sponsored by Groupe SEBBIN. The trial plans to enroll 100 participants.