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โ† Trials
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SEBBIN Silicone Gel-filled Testicular Implants

Recruitingn/aAges any - anyAllGroupe SEBBIN
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

2 sites
UZ Gent
Ghent, Belgium
Centre Hospitalier Lyon Sud
Pierre-Bรฉnite, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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