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

NCT07412509 | Not Yet Recruiting

• 1 other identifier: IRB25-1252
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginoplasty; Gender Dysphoria, Adult

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  immediately after baseline visit

Study Arms (1)

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

Other: Use 3D printed patient specific models for patient education

Interventions

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.

Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Assigned Male at birth (AMAB) subjects ≥ 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Gender Dysphoria

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Courtney Cripps

CONTACT

773-834-3631; ccripps@bsd.uchicago.edu

Taylor Chiang

CONTACT

taylor.chiang@uchicagomedicine.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)