RecruitingNot Applicable

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

Belgium100 participantsStarted 2017-09-19

Plain-language summary

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

Who can participate

Age range18 Years – 100 Years

SexALL

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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.

What they're measuring

Explantation-free survival

Timeframe: From date of surgery until the date of explantation or date of death from any cause, whichever came first, assessed up to 120 months postoperatively (assessment at 3 months postoperatively, 1 year postoperatively and then yearly)

Trial details

NCT IDNCT04064671

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09

Contact for this trial

Wesley Verla

+32 9 332 22 76 wesley.verla@uzgent.be

View on ClinicalTrials.gov More Erectile Dysfunction trials