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Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Sponsor: Anthony Costales, MD
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
278
Start Date
2021-05-21
Completion Date
2027-10
Last Updated
2025-10-15
Healthy Volunteers
No
Conditions
Interventions
Surgery with UM
The experimental group will have MIS with the placement of a uterine manipulator
Surgery without UM
The control group will have MIS without the placement of a uterine manipulator
Locations (5)
Cleveland Clinic
Cleveland, Ohio, United States
Baylor College of Medicine- McNair Campus
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Harris Health System - Smith Clinic
Houston, Texas, United States