MedTrace Logo

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

NCT04586959 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2025-10-15

No results posted yet for this study

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

Interventions

DEVICE

Surgery with UM

The experimental group will have MIS with the placement of a uterine manipulator

DEVICE

Surgery without UM

The control group will have MIS without the placement of a uterine manipulator

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Anthony Costales, MD

    lead OTHER

Principal Investigators

  • Anthony Costales, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2027-07-31
Completion
2027-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586959 on ClinicalTrials.gov