Actively Recruiting
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
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
G
Groupe SEBBIN
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to analyze both short and long term outcomes and patient satisfaction after receiving silicone gel-filled testicular implants made by Groupe SEBBIN. The study includes patients of any age who require testicular implant placement due to conditions such as testicular agenesis, atrophy, undescended testicle, tumor, infection, trauma, or as part of gender reassignment surgery. Since testicular loss can cause psychological distress, the study focuses on understanding complications and quality of life impacts related to these implants. The study observes the placement of one or two sterile, bio-compatible silicone gel-filled testicular prostheses manufactured by SEBBIN. These implants are used during surgery upon patient request and are intended for various medical or gender affirmation reasons. Both cisgender and transgender patients receiving these implants are included, with no experimental treatment but monitoring of the implant's safety and performance over time. Participants will be followed for up to two years after surgery to track complications within 90 days post-operation and long term at two years. Researchers will collect data on complication rates and grades as well as patient-reported outcomes including self-esteem, scrotal body image, and satisfaction with the prosthesis using questionnaires at baseline and multiple intervals up to 24 months. The study monitors safety and quality of life changes to provide comprehensive clinical evaluations of these implants.
CONDITIONS
Brief Title
Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any age, adult or child, at the time of testicular implant placement
- Candidates for unilateral or bilateral testicular implant placement
- Patients who have been informed about the study, read the information letter, and provided oral and written consent
- French patients must be affiliated with the French Social Security system
You will not qualify if you...
- Patients with silicone implants outside the scrotal sac, except penile prostheses
- Patients diagnosed with connective tissue diseases such as systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or others
- Patients with inflammatory or non-inflammatory rheumatic diseases including rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, fibromyalgia, or chronic fatigue syndrome
- Patients with other underlying conditions that may delay healing
- Use of custom-designed implants for surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo surgical implantation of one or two testicular prostheses as requested.
1 surgery visit (in-person)
Duration - Within 90 days postoperatively
Participants are monitored for short term complications and recovery within 90 days after surgery.
Approximately 3 follow-up visits (in-person)
Duration - Up to 2 years of follow-up
Participants are observed for long term complications and evaluated on satisfaction and quality of life through questionnaires.
Visits with questionnaires at 3, 6, 12, and 24 months
Trial Site Locations
Total: 1 location
1
University Hospital Ghent
Ghent, East-Flanders, Belgium, 9000
Actively Recruiting
Research Team
A
Anne-Françoise Spinoit, MD, PhD
W
Wietse Claeys, MD
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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