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SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Sponsor
Groupe SEBBIN (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05062733
Collaborator
(none)
60
Enrollment
1
Location
143.4
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observational Study About SEBBIN Gluteal Implants
    Actual Study Start Date :
    Nov 20, 2021
    Anticipated Primary Completion Date :
    Nov 1, 2023
    Anticipated Study Completion Date :
    Nov 1, 2033

    Outcome Measures

    Primary Outcome Measures

    1. Complication rate [At 10 years of follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Clinic "Essential Aesthetics" Den Haag Netherlands 2582

    Sponsors and Collaborators

    • Groupe SEBBIN

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe SEBBIN
    ClinicalTrials.gov Identifier:
    NCT05062733
    Other Study ID Numbers:
    • PEC 20-07-001
    First Posted:
    Sep 30, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prosthesis Failure

    Study Results

    No Results Posted as of Nov 23, 2021