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

NCT07286123 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-12-16

No results posted yet for this 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

  • Gender Dysphoria, Adult

Interventions

PROCEDURE

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.

PROCEDURE

Biopsy

Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.

Sponsors & Collaborators

  • Kerecis Ltd.

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Shubham Gupta, MD · University Hospitals Cleveland Medical Center

Eligibility

Min Age
19 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286123 on ClinicalTrials.gov