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Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)

Recruitingn/aAges 19 Years - 99 YearsMaleUniversity Hospitals Cleveland Medical Center
NCT07286123 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Bottom gender affirming surgery is one of the key steps towards aligning the physical appearance and gender identity in transgender women. This surgery not only helps in reducing gender dysphoria but also significantly improves the quality of life and psychological well-being of the patients. The basic steps of bottom surgery typically involve the creation of a vagina using the skin from genital organs like the testes and penis, construction of the clitoris and labia. This complex surgery aims to create a functional and aesthetically pleasing vaginal canal that allows for sexual activity, urinary function, and a natural appearance. As part of routine care, a special graft (skin-like material) called Kerecis™ is used to line the middle part of the vagina. It is made from North Atlantic cod skin that is treated in the laboratory and made suitable for surgery purposes. It can be used inste

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 19-99 * Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique Exclusion Criteria: * Patients requiring Kerecis for Revision Vaginoplasty * Surgery candidates having Zero depth vaginoplaty (ZDV) * Non-Gender Affirming Vaginoplasty * Cases requiring the utilization of off-the-shelf grafts other than Kerecis * Allergy to fish products * Allergy to local anesthetic (1% lidocaine with epinephrine injection)
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What it tests

  • Tubularized augmented peritoneal cap vaginoplasty
  • Biopsy
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Where

1 site
University Hospitals Cleveland Medical Center
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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