Clinical Trials in Italy / NCT05062733
Recruiting
Observational
SEBBIN Round, Anatomical and Biconvex Gluteal Implants
NCT05062733 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
ComplicationProsthesis Durability
Study 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
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.
Primary outcome measure(s)
- Complication rate — At 10 years of follow-up
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Istituto Estetico Italiano | Roma | Italy | Recruiting |
| Medical Clinic "Essential Aesthetics" | The Hague | Netherlands | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05062733 on ClinicalTrials.gov ↗ ← All trials in Italy