Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.

Trial Details

NCT ID
NCT04586959
Phase
NA
Sponsor
Anthony Costales, MD
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • Surgery with UM
  • Surgery without UM
Locations (sample)
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Houston, Texas, United States|29.76328,-95.36327
  • Houston, Texas, United States|29.76328,-95.36327
  • Houston, Texas, United States|29.76328,-95.36327
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • A subject will be considered eligible for inclusion in this study if all the following criteria are met:
  • Patient must be greater than or equal to 18 years old.
  • Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
  • Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.

For full eligibility, visit ClinicalTrials.gov.

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