Vaginoplasty3D ModelingNCT07412509
Can 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty?
An observational study of Vaginoplasty and Gender Dysphoria, Adult, run by University of Chicago at 1 site in United States.
Trial summary
The project aims to address both clinical and relational gaps in transgender surgical care by improving understanding, communication, and outcomes through this novel integration of personalized 3D technology. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Vaginoplasty, Gender Dysphoria, Adult
- What is being tested?
- Use 3D printed patient specific models for patient education
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to Mar 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be selected based on their attendance to Trans CARE clinic at the University of Chicago, a diagnosis of gender dysphoria, and desire to undergo gender affirming vaginoplasty
Who may be able to join
- Assigned Male at birth (AMAB) subjects ≥ 18 years old who have been evaluated through the Trans CARE Clinic for gender affirmation at the University of Chicago
- Have a diagnosis of gender dysphoria
- Seeking Vaginoplasty
- Able to provide electronic informed consent in English
Who cannot join
- Vulnerable subjects (children, prisoners, pregnant women) will be excluded Participants may withdraw from this study for any reason at any point by actively asking a research team member. All investigations and standard clinical care will be performed at the main campus of The University of Chicago Medicine at 5841 S. Maryland Ave. in Chicago, IL.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taylor Chiang contact
United States1 site
University of Chicago
Chicago, Illinois, 60637
Courtney Cripps, MD, 773-834-3631, ccripps@bsd.uchicago.edu
Taylor Chiang, taylor.chiang@uchicagomedicine.org
About this study
The project aims to address both clinical and relational gaps in transgender surgical care by improving understanding, communication, and outcomes through this novel integration of personalized 3D technology.
The hypothesis is that using 3D models of patient specific anatomy will enhance patient understanding and education into how peritoneal vaginoplasty is done, while also improving surgical planning and therefore outcomes by decreasing OR time and reducing complication rates. The investigators seek to foster stronger physician-patient relationships by improving communication and shared decision-making, ultimately helping transgender patients feel more empowered, engaged, and willing to seek care in the future.
- Conditions
- Vaginoplasty, Gender Dysphoria, Adult
- Being tested
- Use 3D printed patient specific models for patient education
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use 3D printed patient specific models for patient educationOther
To use 3D printing to generate patient-specific models of abdominal and pelvic anatomy to educate patients about the procedure, including risks, benefits, and potential complications.
| Study group | Role | What they receive |
|---|---|---|
| Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria | Assigned Male at birth (AMAB), greater than equal to18 years old who have been evaluated through the Trans CARE Clinic for gender affirmation at the University of Chicago Receives: Other: Use 3D printed patient specific models for patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of 3D-printed patient-specific models for patient education
To use 3D printing to generate patient-specific models of abdominal and pelvic anatomy to educate patients about the procedure, including risks, benefits, and potential complications.
Measured: Baseline
Participant-reported understanding of gender-affirming vaginoplasty following use of 3D models.
To evaluate participant knowledge and satisfaction with use of 3D Models for discussing Gender- affirming vaginoplasty surgery.
Measured: immediately after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginoplastyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412509
- Sponsor's protocol ID
- IRB25-1252
- Acronym
- 3D Modeling
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty?
- ClinicalTrials.gov ID
- NCT07412509
- Acronym / sponsor ID
- 3D Modeling / IRB25-1252
- Conditions
- Vaginoplasty, Gender Dysphoria, Adult
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Feb 2026 (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.
The project aims to address both clinical and relational gaps in transgender surgical care by improving understanding, communication, and outcomes through this novel integration of personalized 3D technology.
The hypothesis is that using 3D models of patient specific anatomy will enhance patient understanding and education into how peritoneal vaginoplasty is done, while also improving surgical planning and therefore outcomes by decreasing OR time and reducing complication rates. The investigators seek to foster stronger physician-patient relationships by improving communication and shared decision-making, ultimately helping transgender patients feel more empowered, engaged, and willing to seek care in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria | – | Other: Use 3D printed patient specific models for patient educationAssigned Male at birth (AMAB), greater than equal to18 years old who have been evaluated through the Trans CARE Clinic for gender affirmation at the University of Chicago |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected based on their attendance to Trans CARE clinic at the University of Chicago, a diagnosis of gender dysphoria, and desire to undergo gender affirming vaginoplasty
Key inclusion criteria (4 listed)
- Assigned Male at birth (AMAB) subjects ≥ 18 years old who have been evaluated through the Trans CARE Clinic for gender affirmation at the University of Chicago
- Have a diagnosis of gender dysphoria
- Seeking Vaginoplasty
- Able to provide electronic informed consent in English
Key exclusion criteria (1 listed)
- Vulnerable subjects (children, prisoners, pregnant women) will be excluded Participants may withdraw from this study for any reason at any point by actively asking a research team member. All investigations and standard clinical care will be performed at the main campus of The University of Chicago Medicine at 5841 S. Maryland Ave. in Chicago, IL.
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 |
|---|---|---|
| Use 3D printed patient specific models for patient educationTo use 3D printing to generate patient-specific models of abdominal and pelvic anatomy to educate patients about the procedure, including risks, benefits, and potential complications. | Other | Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria |
Primary outcome
Use of 3D-printed patient-specific models for patient education
Time frame: Baseline
To use 3D printing to generate patient-specific models of abdominal and pelvic anatomy to educate patients about the procedure, including risks, benefits, and potential complications.
Participant-reported understanding of gender-affirming vaginoplasty following use of 3D models.
Time frame: immediately after baseline visit
To evaluate participant knowledge and satisfaction with use of 3D Models for discussing Gender- affirming vaginoplasty surgery.
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 21 Apr 2026.
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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.
Taylor Chiang contact
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 Vaginoplasty and Gender Dysphoria, Adult, run by University of Chicago 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 21 Apr 2026. 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 Courtney Cripps (773-834-3631, ccripps@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of 3D-printed patient-specific models for patient education (time frame: Baseline). The study lists 2 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 21 Apr 2026.