Can 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty?

NCT07412509 — Not yet recruiting, 20 participants, University of Chicago

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Registry	NCT07412509, acronym 3D Modeling
Status	Not yet recruiting
Study type	Observational
Enrollment	20 (Estimated)
Sponsor	University of Chicago (Other)
Conditions	Vaginoplasty, Gender Dysphoria, Adult
Interventions	Use 3D printed patient specific models for patient education (Other)
Dates	start 2026-05-01 (estimated), primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-02-17, last updated 2026-04-21
Locations	1 site in United States

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria		Other: Use 3D printed patient specific models for patient education	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

Use 3D printed patient specific models for patient education (Other): 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.

+Outcome measures

Primary outcomes

Use of 3D-printed patient-specific models for patient education [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. [immediately after baseline visit]: To evaluate participant knowledge and satisfaction with use of 3D Models for discussing Gender- affirming vaginoplasty surgery.

+Eligibility

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
University of Chicago	Chicago, Illinois	United States