Actively Recruiting

All Genders
NCT04968470

SEBBIN Silicone Gel-filled Testicular Implants

Led by Groupe SEBBIN · Updated on 2024-10-31

100

Participants Needed

2

Research Sites

754 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

SEBBIN Silicone Gel-filled Testicular Implants

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • The patient has silicone implants somewhere else than in the scrotal sac.
  • The patient was diagnosed with systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  • The patient was diagnosed with rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  • The patient was diagnosed with 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

UZ Gent

Ghent, Belgium, 9000

Actively Recruiting

2

Centre Hospitalier Lyon Sud

Pierre-Bénite, France, 69495

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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SEBBIN Silicone Gel-filled Testicular Implants | DecenTrialz