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Metoidioplasty and Phalloplasty Surgery Decision Making

Study acronym: MaPS
StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Interventions modified Show 4 more changesShow less
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description shortened, about 13 words
    • Study title expanded, about 3 words
  2. Primary completion date: Feb 2028 to Feb 2, 2028
    • Study completion date: Mar 2028 to Mar 6, 2028
    v7
  3. Primary completion date: Apr 2026 to Feb 2028
    • Study completion date: Feb 2027 to Mar 2028
    v6
  4. Primary completion date: Jan 2026 to Apr 2026v5
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date changed from estimate of Oct 7, 2024 to Oct 23, 2024v3
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date: Aug 2024 to Oct 7, 2024
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site contacts updated at 2 of 2 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to test a new online tool designed to provide clear and understandable information to help individuals considering Metoidioplasty and Phalloplasty Surgeries (MaPS) make informed decisions The main questions it aims to answer are: * How user-friendly is the decision aid for individuals considering metoidioplasty and phalloplasty? * Does using the decision aid reduce uncertainty and improve readiness for making surgery decisions compared to usual care? Participants in this study will: * Be randomly assigned to either 1) receive usual care or 2) test the web-based decision aid. * Share their feedback on the tool's usability and its helpfulness in supporting decision-making. * Complete surveys before and after using the decision aid to measure any changes in their decision-making process. Researchers will compare participants who used the decision aid with those who received standard care to see if the decision aid reduces decisional uncertainty and improves readiness for surgery.
Trial Details
NCT Number NCT06565663
Lead Sponsor Dartmouth-Hitchcock Medical Center
Collaborators: University of Utah, Dartmouth College, National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Gender Dysphoria, Gender Dysphoria, Adult, Gender Incongruence, Transgenderism, Transsexualism, Transgender Persons, Phalloplasty
Related terms Gender Dysphoria, Transsexualism
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov