NCT05097820

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 0 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Testicular Cancer
• Testicular Torsion
• Gender Dysphoria
• Undescended Testes
• Orchitis
• Testicular Agenesis
• Testicular Atrophy
• Prosthesis Durability

Interventions

Type	Name	Description
DEVICE	Placement of testicular prosthesis	The surgical implantation of one or two testicular prostheses on request of the patient

Timeline

• Start date: 2021-02-05
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2021-10-28
• Last updated: 2024-09-19

Locations

1 site across 1 country: Belgium