Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

NCT ID: NCT05097820

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-05
• Study Completion Date: 2030-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cisgender patients

All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons.

Placement of testicular prosthesis

Intervention Type: DEVICE

The surgical implantation of one or two testicular prostheses on request of the patient

Transgender patients

All transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery.

Placement of testicular prosthesis

Intervention Type: DEVICE

The surgical implantation of one or two testicular prostheses on request of the patient

Interventions

Placement of testicular prosthesis

The surgical implantation of one or two testicular prostheses on request of the patient

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe SEBBIN

INDUSTRY

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Françoise Spinoit, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

University Hospital Ghent

Ghent, East-Flanders, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Anne-Françoise Spinoit, MD, PhD

Role: CONTACT

anne-francoise.spinoit@uzgent.be

003293322276

Wietse Claeys, MD

Role: CONTACT

wietse.claeys@uzgent.be

003293322276

Facility Contacts

Anne-Françoise Spinoit, MD, PhD

Role: primary

anne-francoise.spinoit@uzgent.be

003293322276

Wietse Claeys, MD, PhD

Role: backup

wietse.claeys@uzgent.be

003293321702

Anne-Françoise Spinoit, MD, PhD

Role: backup

Wietse Claeys, MD

Role: backup

Celine Sinatti, MD

Role: backup

Other Identifiers

BC-8299

Identifier Type: -

Identifier Source: org_study_id