Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Testicular Cancer Clinical Trial

Official title:

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097820
• Other study ID #: BC-8299
• Status: Recruiting
• Start date: February 5, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: December 2023
• Source: University Hospital, Ghent
• Contact: Anne-Françoise Spinoit, MD, PhD
• Phone: 003293322276
• Email: anne-francoise.spinoit[@]uzgent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cryptorchidism
• Gender Dysphoria
• Orchitis
• Prosthesis Durability
• Prosthesis Failure
• Spermatic Cord Torsion
• Testicular Cancer
• Testicular Neoplasms
• Testicular Torsion
• Undescended Testes

Intervention

Device:
• Placement of testicular prosthesis
The surgical implantation of one or two testicular prostheses on request of the patient

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Groupe SEBBIN

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term complication rate	Cathegorized according to Clavien-Dindo Classification	Within 90 days postoperatively
Primary	Long term complication rate	Desciption of overall complications related to testicular prosthesis placement.	At 2 years of follow-up
Secondary	Change in self-esteem scoring	Assessed by the Rosenberg Self-Esteem Scale (strongly disagree - strongly agree)	Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Secondary	Body image of scrotum	Assessed with non-validated likert scale quationnaires	Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Secondary	Satisfaction with prosthesis	Assessed with non-validated likert scale quationnaires	Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up