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SEBBIN Silicone Gel-filled Testicular Implants

Sponsor
Groupe SEBBIN (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04968470
Collaborator
(none)
100
Enrollment
2
Locations
143.5
Anticipated Duration (Months)
50
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular 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 :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants
    Actual Study Start Date :
    Mar 16, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2033

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The patient is an adult or a child at the time of implant placement with SEBBIN implant.

    • The patient is candidate to a unilateral or bilateral testicular implant placement with SEBBIN implant.

    • The patient has been informed of the study, has read the patient information letter and -provided oral consent.

    Exclusion Criteria:

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

    • 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.

    • Custom-designed implants are used for surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Gent Gent Belgium 9000
    2 Centre Hospitalier Lyon Sud Pierre-Bénite France 69495

    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:
    NCT04968470
    Other Study ID Numbers:
    • PEC 19-05-001
    First Posted:
    Jul 20, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Jul 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