NCT05097820 Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
| NCT ID | NCT05097820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Testicular Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-02-05 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-02-05 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
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.
Contact & Investigator
Anne-Françoise Spinoit, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT05097820 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 110 Years, studying Testicular Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05097820 currently recruiting?
Yes, NCT05097820 is actively recruiting participants. Contact the research team at anne-francoise.spinoit@uzgent.be for enrollment information.
Where is the NCT05097820 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT05097820 clinical trial?
NCT05097820 is sponsored by University Hospital, Ghent. The principal investigator is Anne-Françoise Spinoit, MD, PhD at University Hospital, Ghent. The trial plans to enroll 100 participants.
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