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
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
University Hospital, Ghent
100 participants
Sep 19, 2017
OBSERVATIONAL
Conditions
Summary
This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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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Interventions
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)
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NCT04064671