Actively Recruiting

Age: 18Years +
All Genders
NCT05062733

SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Led by Groupe SEBBIN · Updated on 2024-10-31

60

Participants Needed

2

Research Sites

692 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient is a man or a woman 18 years old or older 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Istituto Estetico Italiano

Roma, Italy, 00193

Actively Recruiting

2

Medical Clinic "Essential Aesthetics"

The Hague, Netherlands, 2582

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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