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New balloon procedure may ease heavy periods without major surgery

NCT ID NCT03670680

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new device called Lina Librata that uses a balloon to destroy the lining of the uterus in women with heavy menstrual bleeding. The goal was to see if it works well and causes less pain, so it can be done in an outpatient clinic with local anesthesia. The study included 38 women aged 40-50 who did not want more children. The main measure was whether periods stopped completely.

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

38 people

The number who actually took part.

Started

Oct 2018

Finished

Sep 2025

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

38 to 55 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: * Women from 40 to 50 years old * Not menopausal women * Do not want pregnancy * Having dysfunctional bleeding * informed and signed consent Exclusion Criteria: * Unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc * Pregnancy or wish to have later pregnancy * Endometrium cancer (or suspicious of cancer) or precancerous conditions of the endometrium * Anatomical conditions (i-e history of caesarian, transmural myomectomy) or pathological conditions (i-e long term treatment) which can weaken myometrium * Genital or urinary infection at the time of the procedure * Intra uterine device * Pelvic inflammation * Inability to understand information provided * Not covered by a national health insurance scheme, prisoner or under administrative supervision

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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.

Menorrhagia

Contacts and locations

Locations

  • Hospices Civils de Lyon

    Bron, 69500, France

More trials for these conditions

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