NCT05062733 SEBBIN Round, Anatomical and Biconvex Gluteal Implants
| NCT ID | NCT05062733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Groupe SEBBIN |
| Condition | Complication |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-11-20 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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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 60 participants in total. It began in 2021-11-20 with a primary completion date of 2025-03.
⚠ 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 gluteal 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 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.
Frequently Asked Questions
Who can join the NCT05062733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT05062733 currently recruiting?
Yes, NCT05062733 is actively recruiting participants. Visit ClinicalTrials.gov or contact Groupe SEBBIN to inquire about joining.
Where is the NCT05062733 trial being conducted?
This trial is being conducted at Roma, Italy, The Hague, Netherlands.
Who is sponsoring the NCT05062733 clinical trial?
NCT05062733 is sponsored by Groupe SEBBIN. The trial plans to enroll 60 participants.