Recruiting

Uterine Manipulator

Sponsor:

Anthony Costales, MD

Code:

NCT04586959

Conditions

ENDOMETRIAL CANCER

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Surgery with UM

Surgery without UM

Study Details

Brief 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.

Conditions

ENDOMETRIAL CANCER

Study ID

NCT04586959

Start date

May 21, 2021

Status verified date

Oct, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

278 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surgery With UM (Arm MAN UA)

Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)

active comparator: Surgery Without UM (Arm Control)

Subjects that undergo a MIS approach without a uterine manipulator (control arm)

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

Primary outcome measure

  • Positive peritoneal cytology (PC) [ Time Frame: Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group ]

Central Contacts and Locations

Central contacts

Anthony Costales, MD

713-798-3495costales@bcm.edu

Roberto Vargas, MD

216-444-3414vargasr@ccf.org

Locations

Baylor College of Medicine- McNair Campus

Recruiting

Houston, Texas, United States, 77030

Contacts

Anthony Costales, MD

713-798-3495costales@bcm.edu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Anthony Costales, MD

713-798-3495costales@bcm.edu

Ben Taub General Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Anthony Costales, MD

713-798-3495costales@bcm.edu

Harris Health System - Smith Clinic

Recruiting

Houston, Texas, United States, 77054

Contacts

Anthony Costales, MD

713-798-3495costales@bcm.edu

More Information

Sponsor

Anthony Costales, MD

Last update posted

Oct 15, 2025

Last verified

Oct, 2025

Keywords

  • endometrial
  • cancer
  • uterine
  • manipulator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anthony Costales, MD on 2025-10-15.