Gender Dysphoria, AdultNCT07286123
Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
An observational study of Gender Dysphoria, Adult, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 99 years, men only
- Conditions the study is for
- Gender Dysphoria, Adult
- What is being tested?
- Tubularized augmented peritoneal cap vaginoplasty and Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Individuals requiring graft-based vaginoplasty
Who may be able to join
- Age 19-99
- Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Seyed Sajjad Tabei, MD, 216-844-8963, seyedsajjad.tabei@uhhospitals.org
About this study
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.
Read more
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
- Being tested
- Tubularized augmented peritoneal cap vaginoplasty, Biopsy
- Keywords
- xenograft, gender affirming vaginoplasty, bottom surgery
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubularized augmented peritoneal cap vaginoplastyProcedure or surgery
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.
BiopsyProcedure or surgery
Biopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina.
| Study group | Role | What they receive |
|---|---|---|
| Individuals receiving vaginoplasty | Individuals requiring graft-based vaginoplasty Receives: Procedure: Tubularized augmented peritoneal cap vaginoplasty; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Neovaginal Epithelialization
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
Measured: Six months post-op
Change in Vaginal Diameter
The participants' vaginal diameter is calculated based on the largest tolerated vaginal dilator size (Soul Source; CA, USA) . Measurements are reported in centimeters (cm).
Measured: Post-op week 2, week, 12, month 6, and year 1
Change in Vaginal Depth
The participants' vaginal depth are calculated based on the largest tolerated vaginal dilator (Soul Source, CA, USA). Measurements are reported in centimeters (cm).
Measured: 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)
This is a validated questionnaire measuring health-related quality of life through eight domains, covering physical and mental well-being. It's widely used in healthcare to assess overall health perception and functional status. With higher scores indicating greater quality of life.
Measured: 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)
This is a concise validated questionnaire used to evaluate the severity and impact of pain experienced by individuals. It consists of questions that assess the intensity of pain at its worst, least, average, and current levels, as well as its interference with various aspects of daily life such as general activity, mood, walking ability, work, relationships, and enjoyment of life. Higher scores indicate worse outcomes.
Measured: Week 2, Week 12, Month 6, and year 1 post-op
Change in Pain as measured by the The Female Genitourinary Pain Index (GUPI)
This is a validated questionnaire used to assess symptoms related to genitourinary pain in women. It includes questions covering pain severity, urinary symptoms, and impact on quality of life, providing clinicians with a standardized tool to evaluate and monitor participants' symptoms and treatment responses in these chronic pain conditions. Higher scores indicate worse outcomes.
Measured: 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)
This is a patient-reported scale that measures how individuals perceive their overall improvement after treatment, offering clinicians insight into treatment effectiveness from the participant's viewpoint. Lower scores indicate better outcomes.
Measured: 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)
This is a validated 19-item questionnaire assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored, and the total score reflects overall sexual function, with higher scores indicating better function. It is used in clinical and research settings to evaluate sexual health and the impact of treatments. Higher scores indicate better outcomes.
Measured: Month 6, and year 1 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start22 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Dysphoria, AdultStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kerecis Ltd.
- Responsible party
- Principal investigator, Shubham Gupta, University Hospitals Cleveland Medical Center
- Investigators
- Shubham Gupta, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286123
- Sponsor's protocol ID
- STUDY20250076
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Affirming Vaginoplasty With Tubularized Augmented Peritoneal Cap (TAPCap) Utilizing Fish Skin Xenograft (Kerecis™)
- ClinicalTrials.gov ID
- NCT07286123
- Acronym / sponsor ID
- STUDY20250076
- Conditions
- Gender Dysphoria, Adult
- Keywords
- xenograft, gender affirming vaginoplasty, bottom surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Kerecis Ltd.
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals receiving vaginoplasty | – | Procedure: Tubularized augmented peritoneal cap vaginoplasty, Procedure: BiopsyIndividuals requiring graft-based vaginoplasty |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals requiring graft-based vaginoplasty
Key inclusion criteria (2 listed)
- Age 19-99
- Transgender women planning for gender affirming robotic vaginoplasty with TAPCap technique
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tubularized augmented peritoneal cap vaginoplastyIn 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 or surgery | Individuals receiving vaginoplasty |
| BiopsyBiopsies will be obtained at 6 months post-op from the distal, middle, and proximal portions of the neovagina. | Procedure or surgery | Individuals receiving vaginoplasty |
Primary outcome
Degree of Neovaginal Epithelialization
Time frame: Six months post-op
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
Change in Vaginal Diameter
Time frame: Post-op week 2, week, 12, month 6, and year 1
The participants' vaginal diameter is calculated based on the largest tolerated vaginal dilator size (Soul Source; CA, USA) . Measurements are reported in centimeters (cm).
Change in Vaginal Depth
Time frame: Post-op week 2, week, 12, month 6, and year 1
The participants' vaginal depth are calculated based on the largest tolerated vaginal dilator (Soul Source, CA, USA). Measurements are reported in centimeters (cm).
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
This is a validated questionnaire measuring health-related quality of life through eight domains, covering physical and mental well-being. It's widely used in healthcare to assess overall health perception and functional status. With higher scores indicating greater quality of life.
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
This is a concise validated questionnaire used to evaluate the severity and impact of pain experienced by individuals. It consists of questions that assess the intensity of pain at its worst, least, average, and current levels, as well as its interference with various aspects of daily life such as general activity, mood, walking ability, work, relationships, and enjoyment of life. Higher scores indicate worse outcomes.
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
This is a validated questionnaire used to assess symptoms related to genitourinary pain in women. It includes questions covering pain severity, urinary symptoms, and impact on quality of life, providing clinicians with a standardized tool to evaluate and monitor participants' symptoms and treatment responses in these chronic pain conditions. Higher scores indicate worse outcomes.
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
This is a patient-reported scale that measures how individuals perceive their overall improvement after treatment, offering clinicians insight into treatment effectiveness from the participant's viewpoint. Lower scores indicate better outcomes.
Change in sexual function of improvement as measured by the Female Sexual Function Index (FSFI)
Time frame: Month 6, and year 1 post-op
This is a validated 19-item questionnaire assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored, and the total score reflects overall sexual function, with higher scores indicating better function. It is used in clinical and research settings to evaluate sexual health and the impact of treatments. Higher scores indicate better outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shubham Gupta, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, Adult, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyed Sajjad Tabei, MD (216-844-8963, seyedsajjad.tabei@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Neovaginal Epithelialization (time frame: Six months post-op). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.