Recruiting

Kerecis™ Vaginoplasty

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07286123

Conditions

Gender Dysphoria, Adult

Eligibility Criteria

Sex: Male

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Tubularized augmented peritoneal cap vaginoplasty

Biopsy

Study Details

Brief 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

Study ID

NCT07286123

Start date

Jul 22, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 19 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals receiving vaginoplasty

Individuals requiring graft-based vaginoplasty

Interventions

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.

Biopsy

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

Primary outcome measure

  • Degree of Neovaginal Epithelialization [ Time Frame: Six months post-op ]
  • Change in Vaginal Diameter [ Time Frame: Post-op week 2, week, 12, month 6, and year 1 ]
  • Change in Vaginal Depth [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Week 2, Week 12, Month 6, and year 1 post-op ]
  • Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Month 6, and year 1 post-op ]

Central Contacts and Locations

Central contacts

Seyed Sajjad Tabei, MD

216-844-8963seyedsajjad.tabei@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Seyed Sajjad Tabei, MD

216-844-8963seyedsajjad.tabei@uhhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • xenograft
  • gender affirming vaginoplasty
  • bottom surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2025-12-16.