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Controversial tool under scrutiny: could a simple device raise cancer recurrence risk?

NCT ID NCT05687084

Knowledge-focused Sponsor: Universita di Verona 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial is testing whether using a uterine manipulator during minimally invasive hysterectomy for endometrial cancer affects the chance of cancer coming back. About 1,030 women with early-stage endometrial cancer will be randomly assigned to have surgery with or without the device. The goal is to provide clear evidence on whether the manipulator is safe or should be avoided.

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 device
What this could lead to
If it works, this could show that using a uterine manipulator is safe, or that avoiding it reduces cancer recurrence risk.
What could go wrong
This is a large but early-stage trial comparing a device already in use; results may show no difference or be inconclusive.

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 1,030 people

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

Started

Jan 2023

Expected to finish

Dec 2031

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 100 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: * Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade * Planned surgical treatment including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion) * Age ≥ 18 years * No preoperative evidence of extrauterine disease (Clinical stage IIIA, IIIB) * No preoperative evidence of suspicious lymph nodes (Clinical stage IIIC) * No preoperative evidence of distant metastasis (Clinical stage IV) * Approved and signed informed consent Exclusion Criteria: * Neoadjuvant therapy * Synchronous or previous (\< 5 years) invasive cancer, not including non-melanoma skin cancer * Fertility preservation * World Health Organization performance score \> 2 * Uterine sarcoma * Previous pelvic/abdominal radiotherapy, hormone therapy for cancer (\< 5 years), chemotherapy (\< 5 years), pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery * Inadequate bone marrow function (white blood cells \<3·0×109/L, platelets \<100×109/L) * Inadequate liver function (bilirubin \>1.5×upper normal limit \[UNL\], aspartate aminotransferase, and alanine aminotransferase \>2.5 × UNL) * Inadequate kidney function (creatinine clearance \< 60 mL per min calculated according to Cockcroft-Gault 10 or \< 50 mL per min Ethylenediaminetetraacetic acid clearance) * Intraoperative evidence of stage IV disease

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Conditions

The condition(s) this trial relates to.

endometrial carcinoma endometrium neoplasm

As listed by the trial registrant

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

Endometrial neoplasms

How to take part

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

  1. The places running it

    3 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

  • AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

    RECRUITING

    Verona, 37125, Italy

  • UOC Ostetricia e Ginecologia, Arcispedale Santa Maria Nuova

    RECRUITING

    Reggio Emilia, Italy

  • UOC Ostetricia e Ginecologia, Azienda Ospedaliera Santa Croce e Carle

    RECRUITING

    Cuneo, Italy, 12100, Italy

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