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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

NCT04064671 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-01-30

No results posted yet for this study

Summary

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

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wesley Verla · Dept. of Urology, Ghent University Hospital

  • Piet Hoebeke · Dept. of Urology, Ghent University Hospital

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2027-09-30
Completion
2029-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04064671 on ClinicalTrials.gov