Evaluation of SEBBIN silicone gel-filled gluteal implants
Prospective Observational Study About SEBBIN Gluteal Implants
This study is testing how safe and effective SEBBIN silicone gel-filled gluteal implants are for patients getting them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe SEBBIN Industry-sponsored |
| Locations | 2 sites (Roma and 1 other locations) |
| Trial ID | NCT05062733 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of SEBBIN silicone gel-filled gluteal implants. It involves collecting data from patients who are scheduled to receive these implants, focusing on complications and the durability of the prosthesis. Participants will provide informed consent and will be monitored for outcomes related to the implants. The study is designed to enhance the understanding of the device's performance in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are planning for unilateral or bilateral gluteal implant placement using SEBBIN implants.
Not a fit: Patients with silicone implants in other body areas or those requiring custom-designed implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and longevity of gluteal implants, improving patient outcomes.
How similar studies have performed: While this study is observational, similar studies evaluating silicone implants have shown promising results regarding safety and effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient is a man or a woman ≥ 18 years old at the time of inclusion. * The patient is planned for a unilateral or bilateral gluteal implant placement with SEBBIN implants as per investigator decision * The patient has been informed of the study, has read the patient informed consent and provided consent for the study in writing. Exclusion Criteria: * Patient implanted with silicone implants somewhere else in the body. * Patient candidate for implantation with custom-designed implants. * Participation in another interventional clinical study (participation into an observational study is permitted) with a medicinal product or a medical device in the 30 days prior to enrolment.
Where this trial is running
Roma and 1 other locations
- Istituto Estetico Italiano — Roma, Italy (Recruiting)
- Medical Clinic "Essential Aesthetics" — The Hague, Netherlands (Recruiting)
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.