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
Launched by UNIVERSITY HOSPITAL, GHENT · Aug 19, 2019
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
The ZEPHYR clinical trial is studying the results of a specific surgical procedure involving the Zephyr ZSI 475 FTM inflatable penile implant. This implant is being tested in patients who have undergone female-to-male sex reassignment surgery and may experience erectile dysfunction. The goal of the study is to evaluate how well this implant works in creating a functional neophallus, which is a surgically created penis.
To participate in the trial, individuals must be at least 18 years old, be female-to-male transsexual patients, and be willing to receive the Zephyr ZSI 475 FTM implant. Participants will be asked to provide informed consent, which means they agree to take part in the study after understanding what it involves. The study is currently recruiting participants, so if you meet the criteria and are interested, you can learn more about what to expect from the procedure and the follow-up care involved.
Gender
ALL
Eligibility criteria
- 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.
About University Hospital, Ghent
University Hospital Ghent is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. Located in Ghent, Belgium, the hospital is affiliated with Ghent University, fostering a collaborative environment that integrates cutting-edge medical research with high-quality patient care. With a diverse range of specialized departments and a dedicated team of researchers and clinicians, University Hospital Ghent is at the forefront of developing new therapies and improving treatment protocols, aiming to enhance patient outcomes and contribute to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ghent, Oost Vlaanderen, Belgium
Patients applied
Trial Officials
Wesley Verla
Study Director
Dept. of Urology, Ghent University Hospital
Piet Hoebeke
Principal Investigator
Dept. of Urology, Ghent University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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