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Balloon in the womb: new device aims to save babies with underdeveloped lungs

NCT ID NCT04931212

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 (Smart-TO) that places a small balloon in the windpipe of unborn babies with congenital diaphragmatic hernia, a condition where the diaphragm has a hole and the lungs don't grow properly. The balloon is later removed using a special MRI technique. The goal was to see if the device works and is safe. 23 pregnant women participated, and the study focused on whether the balloon deflated and came out as planned, and on any side effects like early birth.

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

23 people

The number who actually took part.

Started

Aug 2021

Finished

Sep 2024

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 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: * Patients aged 18 years or more, who are able to consent, and affiliated to social security * Singleton pregnancy with fetus with isolated left-sided congenital diaphragmatic hernia (no additional malformation nor chromosomal abnormality) and: Severe pulmonary hypoplasia defined as observed on expected 'lung-to-head ration' (O/E LHR) \<25% irrespective of the liver position as measured between 27wks and 29wks + 6 days Or Moderate pulmonary hypoplasia defined as O/E LHR 25-34.9% (liver up or down) or O/E LHR 35-44.9% with liver up as measured between 30wks and 31wks + 6 days Exclusion Criteria: * Maternal contraindication to fetoscopic surgery * Preterm premature rupture of the membranes (PPROM) or condition strongly predisposing to PPROM or premature delivery * Impossibility of remain close to the FETO center during the fetal occlusion period

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Conditions

The condition(s) this trial relates to.

congenital diaphragmatic hernia pulmonary hypoplasia

As listed by the trial registrant

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

Congenital diaphragmatic hernia

Contacts and locations

Locations

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Béclère

    Clamart, 92140, France

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