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NCT05062733 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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