Status:
RECRUITING
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
Lead Sponsor:
University Hospital, Ghent
Conditions:
Erectile Dysfunction
Gender Dysphoria
Eligibility:
All Genders
18-100 years
Brief Summary
This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.
Detailed Description
Obtaining erectile function after phalloplasty in female-to-male transsexuals remains a challenging issue and requires the implantation of a device. For biological males, several erectile implants exi...
Eligibility Criteria
Inclusion
- 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
- Absence of signed written informed consent.
- Age \< 18 years.
- Biological males.
- Patients opting for penile implants other than the Zephyr ZSI 475 FTM.
Key Trial Info
Start Date :
September 19 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04064671
Start Date
September 19 2017
End Date
December 1 2029
Last Update
January 30 2024
Active Locations (1)
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1
Department of Urology, Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000