SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Recruiting

• Conditions: Complication; Prosthesis Durability

• Registration Number: NCT05062733
• Lead Sponsor: Groupe SEBBIN

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-30
• Study Start: 2021-11-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-03
• Study Completion: 2035-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication rate	At 10 years of follow-up

Trial Locations

Locations (2)

Istituto Estetico Italiano; 🇮🇹 Roma, Italy

Medical Clinic "Essential Aesthetics"; 🇳🇱 Den Haag, Netherlands