[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07412509":3,"trial-entities:NCT07412509":79,"trial-summary:NCT07412509":83},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":16,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":43,"std_ages":51,"locations":54,"central_contacts":72,"overall_officials":76,"references":77,"see_also_links":78},"NCT07412509","IRB25-1252","Can 3D Modeling Enhance Patient Understanding, Education, and Surgical Outcomes in Gender Affirming Peritoneal Vaginoplasty?","NOT_YET_RECRUITING","2027-03","2026-04","2026-04-21","2026-05","University of Chicago","OTHER",false,"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.\n\nThe 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.",null,[18,19],"Vaginoplasty","Gender Dysphoria, Adult",[],"OBSERVATIONAL",[],{"count":24,"type":25},20,"ESTIMATED",[27],{"type":13,"name":28,"description":29,"armGroupLabels":30},"Use 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.",[31],"Adults Assigned Male at birth (AMAB) diagnosed with gender dysphoria",[33,36],{"measure":34,"description":29,"timeFrame":35},"Use of 3D-printed patient-specific models for patient education","Baseline",{"measure":37,"description":38,"timeFrame":39},"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",[],"MALE","18 Years",{"inclusion":44,"exclusion":48,"raw_text":50},[45,46,47],"Have a diagnosis of gender dysphoria","Seeking Vaginoplasty","Able to provide electronic informed consent in English",[49],"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.","Inclusion Criteria:\n\nAssigned 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\n\n* Have a diagnosis of gender dysphoria\n* Seeking Vaginoplasty\n* Able to provide electronic informed consent in English\n\nExclusion Criteria:\n\n* 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.",[52,53],"ADULT","OLDER_ADULT",[55],{"facility":12,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":69},"Chicago","Illinois","60637","United States",[61,66],{"name":62,"role":63,"phone":64,"email":65},"Courtney Cripps, MD","CONTACT","773-834-3631","ccripps@bsd.uchicago.edu",{"name":67,"role":63,"email":68},"Taylor Chiang","taylor.chiang@uchicagomedicine.org",{"lat":70,"lon":71},41.85003,-87.65005,[73,75],{"name":74,"role":63,"phone":64,"email":65},"Courtney Cripps",{"name":67,"role":63,"email":68},[],[],[],{"nct_id":4,"conditions":80,"biomarkers":82},[81],"Gender Dysphoria",[],{"nct_id":4,"found":84,"summary":85,"prompt_version":95},true,{"design":86,"status":87,"heading":88,"summary":89,"follow_up":90,"word_count":91,"commitments":92,"compensation":93,"drugs_mentioned":94},"This is an observational study involving 20 participants. It is not specified if it is randomized or blinded.","completed","3D Models for Vaginoplasty Education and Outcomes","This study is looking at whether using 3D printed models of your own body can help you better understand gender-affirming peritoneal vaginoplasty (a type of surgery to create a vagina). Researchers want to see if these models improve patient education, communication with doctors, and potentially lead to better surgical results like shorter operating room times and fewer complications. You might be able to join if you are an adult assigned male at birth (AMAB), are at least 18 years old, have been diagnosed with gender dysphoria, are seeking vaginoplasty, and can give consent in English. The study aims to enroll 20 participants. Success will be measured by how well you understand the surgery after using the 3D models.","Your understanding will be measured immediately after the baseline visit. No further follow-up is specified.",118,"You would use 3D printed patient-specific models for education during a baseline visit. Your understanding of the surgery will be measured immediately after this visit.","Not stated in the trial record.",[],"v2"]