SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Recruiting now

Conditions studied: Complication, Prosthesis Durability

In brief

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.

Key facts

Study ID

NCT05062733

Run by

Groupe SEBBIN

People needed

60

Starts

2021-11-20

Expected to finish

2035-03-01

Last updated by the study team

2024-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Istituto Estetico Italiano — Roma, Italy (enrolling)
• Medical Clinic "Essential Aesthetics" — The Hague, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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