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Идёт набор NCT07286123

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

— Наблюдательное Gender Dysphoria, Adult

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tubularized augmented peritoneal cap vaginoplasty, Biopsy.
Кому может быть актуально
Состояния в реестре: Gender Dysphoria, Adult. Базовые параметры: 19 лет — 99 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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 instead of skin. This graft has been given permission by the Food and Drug Administration (FDA) for marketing the US. This study aims to identify changes in healing parameters following Kerecis™ based vaginoplasty. Up to 20 participants for this study. Participants will be asked to fill out study questionnaires during follow-up visits at post-op week 2, week 12, month , and year 1. At the 6 month post-op follow up, punch biopsies will be obtained from the deepest part, middle part, and the vaginal part most near to the vaginal opening parts to check the healing process using a microscope. The punch biopsies will be 1/8th inch x 1/8th inch each.

Вмешательства

  • Процедура Tubularized augmented peritoneal cap vaginoplasty
    In this surgery, the distal portion of the neovagina is constructed using inverted penile skin, the proximal portion is made of peritoneal tissue. The area in between peritoneal tissue and penile skin is lined with the Kerecis graft in this standard of care surgery.
  • Процедура Biopsy
    Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.

Первичные конечные точки

  • Degree of Neovaginal Epithelialization [Срок оценки: Six months post-op]
  • Change in Vaginal Diameter [Срок оценки: Post-op week 2, week, 12, month 6, and year 1]
  • Change in Vaginal Depth [Срок оценки: Post-op week 2, week, 12, month 6, and year 1]
  • Change in quality of life as measured by the Short-Form 36 (SF-36) [Срок оценки: Week 2, Week 12, Month 6, and year 1 post-op]
  • Change in Pain as measured by the Brief Pain Inventory - Short Form (BPI-SF) [Срок оценки: Week 2, Week 12, Month 6, and year 1 post-op]
  • Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI) [Срок оценки: Week 2, Week 12, Month 6, and year 1 post-op]
  • Change in overall perception of improvement as measured by the PGI-I (Patient Global Impression of Improvement) [Срок оценки: Week 2, Week 12, Month 6, and year 1 post-op]
  • Change in sexual function of improvement as measured by the Female Sexual Function Index (FSFI) [Срок оценки: Month 6, and year 1 post-op]

Критерии участия

Критерии включения

  • Age 19-99
  • Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University Hospitals Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT07286123 · STUDY20250076

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗