SEBBIN Round, Anatomical and Biconvex Gluteal Implants

October 30, 2024 updated by: Groupe SEBBIN

Prospective Observational Study About SEBBIN Gluteal Implants

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00193
        • Recruiting
        • Istituto Estetico Italiano
        • Contact:
        • Principal Investigator:
          • Valerio Badiali, MD
  • Netherlands
      • Den Haag, Netherlands, 2582
        • Recruiting
        • Medical Clinic "Essential Aesthetics"
        • Contact:
        • Principal Investigator:
          • Philippe Levan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complication rate
Time Frame: At 10 years of follow-up
At 10 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe SEBBIN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2035

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEC 20-07-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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