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

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

Min Age: 0 YearsMax Age: 110 Years

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.

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.

DEVICEPlacement of testicular prosthesis

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

University Hospital Ghent

Ghent, East-Flanders, Belgium

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NCT05097820