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NCT Number: NCT07412509

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

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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Key information

Conditions

Vaginoplasty Gender Dysphoria Gender Dysphoria, Adult Mental Disorders Sexual Dysfunctions, Psychological

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Cripps

CONTACT

[email protected]

773-834-3631

Taylor Chiang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: 3D Modeling

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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