RecruitingNCT05097820

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants


Sponsor

University Hospital, Ghent

Enrollment

100 participants

Start Date

Feb 5, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 0 YearsMax Age: 110 Years

Plain Language Summary

Simplified for easier understanding

This study is following people who receive a silicone gel testicular implant (called a SEBBIN implant) after losing one or both testicles — for example after cancer treatment, injury, or a birth defect — to track the long-term safety and outcomes of the device. **You may be eligible if...** - You are an adult or child who needs (or recently received) a testicular implant - You are receiving a unilateral or bilateral (one or both sides) testicular implant - You have been informed about the study and signed the consent form - If you are French, you are affiliated with the French Social Security system **You may NOT be eligible if...** - You already have silicone implants elsewhere (other than a penile prosthesis) - You have a connective tissue disease such as lupus, scleroderma, Sjogren syndrome, or rheumatoid arthritis - You have inflammatory joint disease, fibromyalgia, or chronic fatigue syndrome - You have any condition that significantly impairs wound healing - A custom-designed (non-standard) implant is required for your surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPlacement of testicular prosthesis

The surgical implantation of one or two testicular prostheses on request of the patient


Locations(1)

University Hospital Ghent

Ghent, East-Flanders, Belgium

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NCT05097820


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