SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Launched by GROUPE SEBBIN · Sep 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying SEBBIN silicone gel-filled gluteal implants, which are devices used for enhancing the shape and volume of the buttocks. The main goal of this study is to collect more information about how safe and effective these implants are, especially concerning any complications and their durability over time. The trial is currently recruiting participants, and it is open to both men and women aged 18 and older who are planning to have these implants placed.

To be eligible for the study, participants must not have silicone implants in other parts of their body and should not be involved in any other clinical trials that involve a medicine or medical device in the month before joining this study. Before taking part, individuals will be fully informed about the trial and will need to provide written consent. Participants can expect to receive careful monitoring and follow-up to ensure their safety throughout the study. This trial is an important step in understanding how well these gluteal implants work and ensuring they are safe for future patients.

Gender

ALL

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.