RecruitingNCT05062733

SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Prospective Observational Study About SEBBIN Gluteal Implants

Sponsor

Groupe SEBBIN

Enrollment

60 participants

Start Date

Nov 20, 2021

Study Type

OBSERVATIONAL

Conditions

Complication Prosthesis Durability

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria3

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.

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