Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05097820
Study type	Observational [Patient Registry]
Source	University Hospital, Ghent
Contact	Anne-Françoise Spinoit, MD, PhD
Phone	003293322276
Email	anne-francoise.spinoit@uzgent.be
Status	Recruiting
Phase
Start date	February 5, 2021
Completion date	December 31, 2030

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms