SEBBIN Silicone Gel-filled Testicular Implants

Last updated: October 30, 2024
Sponsor: Groupe SEBBIN
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04968470
PEC 19-05-001
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

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

Exclusion

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, orany 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 ordegenerative non-inflammatory rheumatic disease.

  • The patient has a pathology that could delay healing.

  • Custom-designed implants are used for surgery.

Study Design

Total Participants: 100
Study Start date:
March 16, 2021
Estimated Completion Date:
September 30, 2035

Connect with a study center

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Groupe SEBBIN

    Boissy l'Aillerie, 95651
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495
    France

    Active - Recruiting

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