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NCT Number: NCT05062733

SEBBIN Round, Anatomical and Biconvex 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.

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Key information

Conditions

Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Durability Prosthesis Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Estetico Italiano, Roma, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Complication rate

    Time frame: At 10 years of follow-up

Sponsors and collaborators

Lead sponsor

Groupe SEBBIN

Industry

Registry information

Official study title

Prospective Observational Study About SEBBIN Gluteal Implants

Important dates

Study start
2021
Primary completion
2025
Study completion
2035
First posted
Sep 30, 2021
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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