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Recruiting NCT05062733

SEBBIN Round, Anatomical and Biconvex Gluteal Implants

— Observational Complication Prosthesis Durability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Complication, Prosthesis Durability. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Study About SEBBIN Gluteal Implants

Overview

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.

Primary outcome measures

  • Complication rate [Time frame: At 10 years of follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • Istituto Estetico Italiano — Roma
Netherlands · 1 center
  • Medical Clinic "Essential Aesthetics" — The Hague

Identifiers

NCT: NCT05062733 · PEC 20-07-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗