Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Anthony Costales, MD
Study ID
NCT04586959
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Surgery with UM — DEVICE
    The experimental group will have MIS with the placement of a uterine manipulator
  • Surgery without UM — DEVICE
    The control group will have MIS without the placement of a uterine manipulator

Study Details

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 Dates

Start date
May 21, 2021
Status verified
Oct 2025
Primary completion
Jul 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
278 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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)

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

Locations (5)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195-
Baylor College of MedicineHoustonTexas77030
Anthony Costales, MD
[email protected]
713-798-3495
Baylor College of Medicine- McNair CampusHoustonTexas77030
Anthony Costales, MD
[email protected]
713-798-3495
Ben Taub General HospitalHoustonTexas77030
Anthony Costales, MD
[email protected]
713-798-3495
Harris Health System - Smith ClinicHoustonTexas77054
Anthony Costales, MD
[email protected]
713-798-3495

Find similar trials in Cleveland, OH

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Cleveland Clinic· Cleveland, OHBaylor College of Medicine· Houston, TXBaylor College of Medicine- McNair Campus· Houston, TXBen Taub General Hospital· Houston, TXHarris Health System - Smith Clinic· Houston, TX

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