Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 97 of 102 for:    IVERMECTIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064671
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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

Condition or disease Intervention/treatment
Erectile Dysfunction Gender Dysphoria Other: Implantation of the Zephyr ZSI 475 FTM erectile implant

Detailed Description:

Obtaining erectile function after phalloplasty in female-to-male transsexuals remains a challenging issue and requires the implantation of a device. For biological males, several erectile implants exist and widespread research has demonstrated the successful outcome of these devices. However, substantial differences exist between a native penis and a neophallus and explain the poorer outcome of these devices in female-to-male transsexuals.

In 2018, Falcone et al. published the largest retrospective series on this subject so far and reported that after a mean follow-up of 20 months, only 58% of their patients still had their original implant in place. The main obstacle in these female-to-male transsexuals is represented by the lack of corpora cavernosa in the neophallus which leads to difficult anchorage of the prosthesis, little stability of the prosthesis and a higher risk of cylinder erosion.

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.

So far, no literature regarding surgical or functional outcome of the Zephyr ZSI 475 FTM exists. The aim of this study is to prospectively collect data of all female-to-male transsexuals that are treated with the implantation of this device at Ghent University Hospital.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ZEPHYR: A Prospective 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
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : December 2029

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Explantation-free survival [ 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) ]
    Interval between implantation date and explantation date (if explanted)


Secondary Outcome Measures :
  1. Complication rate after implantation of this device [ Time Frame: 90 days after implantation ]
    The Clavien-Dindo system (<90d) to report surgical complications will be used

  2. Type of complications [ 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) ]

    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female-to-male transgenders after phalloplasty
Sampling Method:   Probability Sample
Study 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064671


Contacts
Layout table for location contacts
Contact: Wesley Verla +32 9 332 22 76 wesley.verla@uzgent.be

Locations
Layout table for location information
Belgium
Department of Urology, Ghent University Hospital Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Wesley Verla    +32 9 332 22 76    wesley.verla@uzgent.be   
Sub-Investigator: Wesley Verla, MD         
Principal Investigator: Piet Hoebeke, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Layout table for investigator information
Study Director: Wesley Verla Dept. of Urology, Ghent University Hospital
Principal Investigator: Piet Hoebeke Dept. of Urology, Ghent University Hospital

Layout table for additonal information
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04064671     History of Changes
Other Study ID Numbers: 2019/0025
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
female-to-male
transgender
transsexual
Zephyr
erectile device
erectile implant
neophallus
phalloplasty
gender reassignment surgery
sex reassignment surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Ivermectin
Erectile Dysfunction
Gender Dysphoria
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Abamectin
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics