SEBBIN Round, Anatomical and Biconvex Gluteal Implants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGroupe SEBBIN
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The intended target population for the gluteal Implants is women or men, who desire an increase in volume of the gluteal region for aesthetic or reconstruction reason.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Complication rate
Time frame
At 10 years of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov