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Surgical tool under scrutiny: could it spread cancer cells?

NCT ID NCT04586959

Knowledge-focused Sponsor: Anthony Costales, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is looking at whether using a device called a uterine manipulator during minimally invasive surgery for early stage endometrial cancer causes cancer cells to spread into the abdominal fluid. About 278 women will be randomly assigned to have surgery with or without the device. The main goal is to see if there are cancer cells in the fluid after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Uterine manipulator (a surgical device)
What this could lead to
If it works, this could show that using a uterine manipulator is safe and does not increase the risk of spreading cancer cells during surgery.
What could go wrong
This is an early-stage study looking at lab results, not long-term outcomes. It may not change current surgical practice, and the results might not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 278 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2021

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor College of Medicine- McNair Campus

    RECRUITING

    Houston, Texas, 77030, United States

  • Ben Taub General Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Cleveland Clinic

    SUSPENDED

    Cleveland, Ohio, 44195, United States

  • Harris Health System - Smith Clinic

    RECRUITING

    Houston, Texas, 77054, United States

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