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

Recruiting now

Conditions studied: Erectile Dysfunction, Gender Dysphoria

In brief

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

Key facts

Study ID

NCT04064671

Run by

University Hospital, Ghent

People needed

100

Starts

2017-09-19

Expected to finish

2029-12-01

Last updated by the study team

2024-01-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Absence of signed written informed consent.
• Age < 18 years.
• Biological males.
• Patients opting for penile implants other than the Zephyr ZSI 475 FTM.

Where it is running

• Department of Urology, Ghent University Hospital — Ghent, Oost-Vlaanderen, Belgium (enrolling)

Full record on ClinicalTrials.gov

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