Health Trials

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

ConditionsErectile DysfunctionGender Dysphoria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity Hospital, Ghent

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

Absence of signed written informed consent.

Age < 18 years.

Biological males.

Patients opting for penile implants other than the Zephyr ZSI 475 FTM.

Trial design

Treatments tested in this trial

  • Implantation of the Zephyr ZSI 475 FTM erectile implant

Treatment groups

No treatment groups listed

Sponsors and collaborators

University Hospital, Ghent

Lead sponsor

Source ClinicalTrials.gov