An observational study in Testicular Cancer, Testicular Torsion and Gender Dysphoria, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to participants aged 0 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Observational
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
Testicular implants made from various materials have been in use since 1941. The lack of a testicle has proven to be a psychologically traumatic experience for men of all ages. Therefore, testicular implants are placed in the scrotum for various reasons on request of the patient.The intended target population for the silicone gel-filled testicular implants of Groupe SEBBIN is any patient (children or adults) with agenesis or testicular atrophy, undescended testicle, testicular tumour, epididymitis / orchitis, or a trauma, for whom an orchidectomy with placement of a testicular prosthesis is indicated. Testicular implants are also indicated for sex reassignment surgeries.
The main complications after testicular implant placement recorded in the literature include extrusion, scrotal contraction, pain, hematoma, and infection. The literature about testicular implant is sparse, and no report on the use of SEBBIN silicone gel-filled testicular implants have been identified in the scientific literature.
The Gel-filled Testicular Implant medical devices are manufactured by GROUPE SEBBIN under the brand name 'Laboratoires SEBBIN'. The Gel-filled Testicular Implant medical devices are presented sterile (Ethylene oxide sterilization) and are double wrapped for single use.
The medical grade raw materials used for the manufacturing of these prostheses are bio-compatible and completely traceable. The substances belong to the polydimethylsiloxane family.
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather data on the safety and effectiveness of the device. For this purpose, the overall short and long term complication rate and complication grade. Secondly, the investigators evaluate patient satisfaction and quality of life by use of questionnaires
295 studies on the registry are indexed under Testicular Neoplasms; 51 are open to participants now.
This study's planned enrollment of 100 is below the median of 133 across 73 observational studies indexed under Testicular Neoplasms.
Browse Testicular Neoplasms studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Any undividual with an underlying reason for testicular loss with a specific wish for testicular implant placement.
Any patient with the underlying condidion of gender dysphoria with the specific wish for testicular implant placement as a form of gender reassignment surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons.
Device: Placement of testicular prosthesis
All transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery.
Device: Placement of testicular prosthesis
The surgical implantation of one or two testicular prostheses on request of the patient
Short term complication rate
Cathegorized according to Clavien-Dindo Classification
Time frame: Within 90 days postoperatively
Long term complication rate
Desciption of overall complications related to testicular prosthesis placement.
Time frame: At 2 years of follow-up
Change in self-esteem scoring
Assessed by the Rosenberg Self-Esteem Scale (strongly disagree - strongly agree)
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Body image of scrotum
Assessed with non-validated likert scale quationnaires
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Satisfaction with prosthesis
Assessed with non-validated likert scale quationnaires
Time frame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Plan to share: Undecided — After publication of findings, the individual patient data can be provided upon request.
No publications or documents are linked to this record.
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