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ZEPHYR: A Study Evaluating Surgical Outcome After Implantation of the Zephyr ZSI 475 FTM Inflatable Penile Implant in the Neophallus After Female-to-male Sex Reassignment Surgery

Recruitingn/aAges 18 Years - 100 YearsAllUniversity Hospital, Ghent
NCT04064671 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations. * Age ≥ 18 years. * Female-to-male transsexual patient. * Implantation of Zephyr ZSI 475 FTM erectile device. Exclusion Criteria: * Absence of signed written informed consent. * Age \< 18 years. * Biological males. * Patients opting for penile implants other than the Zephyr ZSI 475 FTM.
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What it tests

  • Implantation of the Zephyr ZSI 475 FTM erectile implant
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Where

1 site
Department of Urology, Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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