Home › Endometrial Cancer › NCT04586959
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Recruiting
Who can join
Ages 18 to 90 · Women
Full eligibility criteria
Inclusion Criteria: A subject will be considered eligible for inclusion in this study if all the following criteria are met: 1. Patient must be greater than or equal to 18 years old. 2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous) 3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively. 4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1). 6\. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure. Exclusion Criteria: A subject must not have any of the following criteria: 1. Planned laparotomic hysterectomy 2. On progesterone therapy to treat their endometrial cancer 3. Any prior pelvic irradiation
About the study
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.
What is being tested
- Surgery with UM (device)
- Surgery without UM (device)
Sponsor: Anthony Costales, MD · Participants: 278 · Started: May 21, 2021
Contact the study team
- Anthony Costales, MD · Phone: 713-798-3495
- Roberto Vargas, MD · Phone: 216-444-3414
Official record on ClinicalTrials.gov — NCT04586959
Locations in the U.S.
| Texas | Baylor College of Medicine, Houston Baylor College of Medicine- McNair Campus, Houston Ben Taub General Hospital, Houston Harris Health System - Smith Clinic, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.