Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

All female-to-male transsexual patients asking for the implantation of an erectile device are carefully counseled and during their visit, all available devices are discussed with their inherent benefits and drawbacks. If the patient independently chooses for the Zephyr ZSI 475 FTM erectile device, and if this patient meets the aforementioned inclusion criteria, he will be included in this study after voluntarily signing the written informed consent form.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Implantation of the Zephyr ZSI 475 FTM erectile implant

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Explantation-free survival

Interval between implantation date and explantation date (if explanted)

Time frame
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)

Secondary outcomes

1

Complication rate after implantation of this device

The Clavien-Dindo system (\<90d) to report surgical complications will be used

Time frame
90 days after implantation
2

Type of complications

Complications that will be assessed, involve: * Urinary tract infection (yes or no) * Hematuria (yes or no) * Wound infection (yes or no) * Wound dehiscence (yes or no) * Abscess formation (yes or no) * Fistula formation (yes or no) * Protrusion of the device (yes or no) * Malfunction of the device (yes or no) * migration of the device (yes or no) * Infection of the device (yes or no)

Time frame
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Source ClinicalTrials.gov
Apply now