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NCT07286123 · ClinicalTrials.gov registry record
Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
A clinical trial of Gender Dysphoria, Adult, sponsored by University Hospitals Cleveland Medical Center.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT07286123: Recruiting study of Gender Dysphoria, Adult, sponsored by University Hospitals Cleveland Medical Center.
NCT07286123 is a study of Gender Dysphoria, Adult that is actively recruiting participants, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07286123, a study of Gender Dysphoria, Adult, is actively recruiting participants, sponsored by University Hospitals Cleveland Medical Center.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Degree of epithelialization of each sample biopsy. Biopsies are obtained from the proximal segment (peritoneal portion), middle segment (Xenograft portion), and, distal segment (penile skin portion) of the neovagina. Grade 0: No epithelialization Grade 1 : Minimal epithelialization Grade 2: Moderate epithelialization Grade 3: Significant epithelialization
Conditions Studied
Interventions
- PROCEDURE Biopsy
- PROCEDURE Tubularized augmented peritoneal cap vaginoplasty
Study Locations (1)
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-07-22 |
| Est. Completion | 2027-06-30 |
What NCT07286123 shows while recruiting
NCT07286123 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 1 condition, with Gender Dysphoria, Adult appearing as the primary indexed condition, and to 2 interventions - of which Biopsy is the first listed.
NCT07286123 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07286123 about?
NCT07286123 is a clinical study titled "Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)". 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 ba...
What is the current status of trial NCT07286123?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2025-07-22. Estimated completion is 2027-06-30.
What conditions does trial NCT07286123 study?
This clinical trial studies the following conditions: Gender Dysphoria, Adult.
What interventions are being tested in trial NCT07286123?
The interventions under investigation include: Biopsy (PROCEDURE), Tubularized augmented peritoneal cap vaginoplasty (PROCEDURE).
Who is sponsoring clinical trial NCT07286123?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07286123 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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