SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Complication Clinical Trial

Official title:

Prospective Observational Study About SEBBIN Gluteal Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062733
• Other study ID #: PEC 20-07-001
• Status: Recruiting
• Start date: November 20, 2021
• Est. completion date: March 2035

Study information

• Verified date: March 2024
• Source: Groupe SEBBIN
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2035
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Prosthesis Durability
• Prosthesis Failure

Locations

Country	Name	City	State
Netherlands	Medical Clinic "Essential Aesthetics"	Den Haag

Sponsors (1)

Lead Sponsor	Collaborator
Groupe SEBBIN

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate		At 10 years of follow-up