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Clinical Trials in Belgium / NCT05097820
Recruiting Observational

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

NCT05097820 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2021-02-05
Last updated
2024-09-19

Condition(s) studied

Testicular CancerTesticular TorsionGender DysphoriaUndescended TestesOrchitisTesticular AgenesisTesticular AtrophyProsthesis Durability

Investigational drug(s) / intervention(s)

Placement of testicular prosthesis

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

Study summary

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

Eligibility

Sex
ALL
Min age
0 Years
Max age
110 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Ghent Ghent East-Flanders Recruiting

More University Hospital, Ghent trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05097820 on ClinicalTrials.gov ↗ ← All trials in Belgium