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Can a reusable device match the standard for uterine biopsy?

NCT ID NCT07745595

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This trial compares two outpatient methods for sampling the lining of the uterus in women with abnormal uterine bleeding. The standard method uses a single-use Pipelle device, while the alternative uses a reusable manual vacuum aspiration (MVA) cannula, which is cheaper and requires no electricity. The study will see if the MVA device provides tissue samples that are just as good for diagnosing conditions like hyperplasia or cancer. If it works, it could offer a more affordable option for diagnosis in low-resource settings.

What this could mean

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

Active substance
Manual Vacuum Aspiration (MVA) cannula compared to Pipelle endometrial suction curette
What this could lead to
If MVA proves as effective as Pipelle, it could offer a cheaper, reusable option for diagnosing uterine conditions, especially in low-resource settings.
What could go wrong
This is a small, early-stage comparison. The MVA device may not match the diagnostic accuracy of the standard Pipelle, and results may not apply to all populations.

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 162 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 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 40 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: 1. Age \> 18 years. 2. Singleton alive pregnancy. 3. History of spontaneous preterm birth (22 to 37 weeks of gestation). 4. Hemoglobin (Hb) \> 10 g/dL. 5. Absence of fetal anomalies on ultrasound examination. Exclusion Criteria: 1. Primigravida. 2. Multiple pregnancy. 3. Maternal age \> 40 years. 4. Known history of allergy or hypersensitivity to aspirin. 5. Known maternal comorbidities including Pregnancy-Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), cardiac disease, HELLP syndrome, thrombocytopenia, thrombocytopathy, or epilepsy. 6. Presence of a cervical cerclage prior to study enrollment.

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Conditions

The condition(s) this trial relates to.

Obstetric Labor, Premature Premature Birth

As listed by the trial registrant

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

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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