SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Prospective Observational Study About SEBBIN Gluteal Implants

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05062733

Enrollment

Registered

2021-09-30

Start date

2021-11-20

Completion date

2035-03-31

Last updated

2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication, Prosthesis Durability

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Complication rate	At 10 years of follow-up

Countries

Italy, Netherlands

Outcome results