Actively Recruiting

Age: 0Years - 110Years
All Genders
NCT05097820

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Led by University Hospital, Ghent · Updated on 2024-09-19

100

Participants Needed

1

Research Sites

516 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

G

Groupe SEBBIN

Collaborating Sponsor

AI-Summary

What this Trial Is About

To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.

CONDITIONS

Official Title

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Who Can Participate

Age: 0Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient is an adult or a child at the time of testicular implant placement.
  • The patient is a candidate for unilateral or bilateral testicular implant placement.
  • The patient has been informed about the study, has read the patient information letter, and provided oral and written consent.
  • If the patient is of French nationality, he/she must be affiliated with the French Social Security.
Not Eligible

You will not qualify if you...

  • The patient has silicone implants somewhere other than the scrotal sac (except for a penile prosthesis).
  • The patient has been diagnosed with systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  • The patient has rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  • The patient has arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
  • The patient has any other underlying condition 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: 1 location

1

University Hospital Ghent

Ghent, East-Flanders, Belgium, 9000

Actively Recruiting

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Research Team

A

Anne-Françoise Spinoit, MD, PhD

CONTACT

W

Wietse Claeys, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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