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IM02: Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants

Sponsor
Groupe SEBBIN (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04968457
Collaborator
(none)
908
Enrollment
156
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    908 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
    Actual Study Start Date :
    Jan 1, 2014
    Anticipated Primary Completion Date :
    Jan 1, 2027
    Anticipated Study Completion Date :
    Jan 1, 2027

    Outcome Measures

    Primary Outcome Measures

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

      complication rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • The patient is at least 18-year-old.

    • The patient is genetically a woman.

    • The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.

    • The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.

    Exclusion Criteria:

    • The patient is pregnant or breastfeeding.

    • The patient has silicone implants somewhere else than in the breast.

    • The patient was diagnosed with one of the following pathologies:

    • Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.

    • Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.

    • Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.

    • The patient has a pathology that could delay healing (does not apply to the reconstruction group).

    • The patient has cancer (does not apply to the reconstruction group).

    • The patient has anatomical or physiological conditions that could lead to postoperative complications.

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT04968457
    Other Study ID Numbers:
    • PEC 15-10-001
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 23, 2022