Can a reusable device match the standard for uterine biopsy?
NCT ID NCT07745595
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
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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
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About 162 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
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.
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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.
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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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