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New uterine sampler aims to make cancer detection less painful

NCT ID NCT04258449

Diagnosis Sponsor: McGill University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new device called DOvEEgene Fleur for collecting cells from inside the uterus to detect cancers of the endometrium, tubes, and ovaries. The goal is to see if it is less painful and easier to use than the current brush, while still collecting enough cells for accurate testing. Forty women with suspected or confirmed gynecological cancer will try the device before surgery.

What this could mean

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

Active substance
DOvEEgene Fleur endometrial sampling device
What this could lead to
If successful, this could lead to a more comfortable and effective way to collect samples for early detection of uterine and ovarian cancers.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to everyone. The device is new and its performance compared to standard tools is still being tested.

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.

Participants

About 40 people

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

Started

Dec 2020

Expected to finish

Oct 2026

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.

Who is studied

The participating hospital runs multiple weekly routine gynecologic oncology clinics. The cases include women scheduled to undergo surgery for tumor removal, for either proven or suspected upper genital tract cancer.

Ages

18 years and older

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: * Be at least 18 years of age. * Have capacity to understand the study. * Be able to provide informed consent. * If the patient has a recently treated cervical abnormality, she must have had a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy. * Have suspected or confirmed cancer of the upper genital tract and be undergoing surgery for said tumor removal. Exclusion Criteria: * Prior hysterectomy. * Be pregnant or possibly pregnant. * Be nursing, as the device contains phthalates (plasticizers) that "have not been fully characterized and there may be concern for reproductive and developmental effects". * Have an infected or inflamed cervix. * Have a confirmed or suspected pelvic infection. * Have a confirmed or suspected vaginal infection. * Have had recent history of uterine perforation. * Patients with recently treated cervical abnormalities must have a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy in order to be eligible.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm fallopian tube cancer female reproductive system disorder ovarian cancer

As listed by the trial registrant

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

Women with suspected or confirmed gynecological disease

How to take part

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

  1. The places running it

    1 site. 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

  • Royal Victoria Hospital (Glen Site)

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.