Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants (NCT05097820) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
Belgium100 participantsStarted 2021-02-05
Plain-language summary
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
Who can participate
Age range0 Years – 110 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient is an adult or a child at the time of testicular implant placement.
* The patient is a candidate to unilateral or bilateral testicular implant placement.
* The patient has been informed of 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 to the French Social Security.
Exclusion Criteria:
* The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).
* 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 any other underlying condition that could delay healing.
\- Custom-designed implants are used for surgery.