Evaluation of SEBBIN silicone gel-filled gluteal implants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituto Estetico Italiano
  Roma, Italy Recruiting
• Medical Clinic "Essential Aesthetics"
  The Hague, Netherlands Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.