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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
Sponsor: University Hospital, Ghent
Summary
This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.
Official title: ZEPHYR: A Prospective 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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2017-09-19
Completion Date
2029-12
Last Updated
2024-01-30
Healthy Volunteers
Not specified
Conditions
Interventions
Implantation of the Zephyr ZSI 475 FTM erectile implant
Until recently, all penile implants were manufactured for erectile dysfunction in biological males and thus presumed the presence of two corpora cavernosa. In 2016 however, the Swiss company, Zephyr Surgical Implants (ZSI), created a 3-piece inflatable erectile device specifically for female-to-male transsexuals: the Zephyr ZSI 475 FTM. This prosthesis has a realistic gland shape, only one cylinder, and a specific anchorage device made of titanium and silicone to anchor the system to the pubic bone of the patient. These specific features could potentially address the aforementioned issues with implanting erectile devices in the neophallus and hopefully lead to better surgical outcomes in these particular patients.
Locations (1)
Department of Urology, Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium