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New study: could a 30-Minute procedure end heavy periods for good?

NCT ID NCT05856838

Symptom relief Sponsor: University Hospital, Ghent 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study looks at whether a procedure called NovaSure radiofrequency ablation can be done safely and comfortably in an outpatient setting for women with heavy menstrual bleeding. The procedure destroys the lining of the uterus to reduce bleeding. Researchers will measure patient satisfaction and pain levels in 30 women aged 35-50 who have not responded to other treatments.

What this could mean

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

Active substance
NovaSure radiofrequency ablation device
What this could lead to
If successful, this could offer women a convenient, same-day procedure to reduce heavy bleeding without needing a hospital stay.
What could go wrong
This is a small, early observational study with only 30 participants, so results may not apply to everyone. The procedure may not fully stop bleeding and some women may need further treatment.

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 30 people

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

Started

Nov 2023

Expected to finish

Dec 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.

Ages

35 to 50 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: * ≥ 35 years - ≤ 50 years * Heavy menstrual bleeding (PBAC ≥ 150) * Unsuccessful drug treatment, contraindication to drug treatment or rejection of drug treatment by the patient * The absence of intra-uterine abnormalities on diagnostic hysteroscopy * Endometrial biopsy (pipelle) is normal * Finished childbearing Exclusion Criteria: * Pregnancy * Endometritis * Adenomyosis * Contra-indication for local anaesthetics * Presence of severe systemic disease (≥ASA 3) * Previously performed endometrial ablation * Poor understanding of Dutch language * History of pelvic malignancy * Presence of an intra uterine device (IUD) * Cavity pathology (myoma, septum) * Cavity length \< 4 cm * Each uterine incision other than conventional caesarean incision

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Conditions

The condition(s) this trial relates to.

Menorrhagia

As listed by the trial registrant

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

Menstrual bleeding, heavy

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

  • Ghent University Hospital

    RECRUITING

    Ghent, East Flanders, 9000, Belgium

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