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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05097820
Other study ID # BC-8299
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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