NCT04064671 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
| NCT ID | NCT04064671 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Erectile Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-09-19 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2017-09-19 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will look into the surgical outcome after implantation of the Zephyr ZSI 475 FTM in the neophallus.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Absence of signed written informed consent. * Age \< 18 years. * Biological males. * Patients opting for penile implants other than the Zephyr ZSI 475 FTM.
Contact & Investigator
Wesley Verla
STUDY DIRECTOR
Dept. of Urology, Ghent University Hospital
Frequently Asked Questions
Who can join the NCT04064671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04064671 currently recruiting?
Yes, NCT04064671 is actively recruiting participants. Contact the research team at wesley.verla@uzgent.be for enrollment information.
Where is the NCT04064671 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT04064671 clinical trial?
NCT04064671 is sponsored by University Hospital, Ghent. The principal investigator is Wesley Verla at Dept. of Urology, Ghent University Hospital. The trial plans to enroll 100 participants.