SEBBIN Silicone Gel-filled Testicular Implants

Recruiting now

Conditions studied: Complication, Prosthesis Durability

In brief

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.

Key facts

Study ID

NCT04968470

Run by

Groupe SEBBIN

People needed

100

Starts

2021-03-16

Expected to finish

2035-09-01

Last updated by the study team

2024-10-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UZ Gent — Ghent, Belgium (enrolling)
• Centre Hospitalier Lyon Sud — Pierre-Bénite, France (enrolling)

Full record on ClinicalTrials.gov

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