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Recruiting NCT04968470

SEBBIN Silicone Gel-filled Testicular Implants

— Observational Complication Prosthesis Durability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Complication, Prosthesis Durability. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Observational Study About SEBBIN Silicone Gel-filled Testicular Implants

Overview

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.

Primary outcome measures

  • Complication rate [Time frame: At 10 years of follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Belgium · 1 center
  • UZ Gent — Ghent
France · 1 center
  • Centre Hospitalier Lyon Sud — Pierre-Bénite

Identifiers

NCT: NCT04968470 · PEC 19-05-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗