SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Sebbin

Status: Enrolling

Conditions: Prosthesis Durability; Complication

Study type: Observational

Funder types: Industry

Identifiers

NCT05062733

PEC 20-07-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.