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Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
NCT07286123 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07286123
The ClinicalTrials.gov registry entry for NCT07286123 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07286123 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07286123?
The interventions under investigation include: Biopsy (PROCEDURE), Tubularized augmented peritoneal cap vaginoplasty (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07286123?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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