Fetoscopic Endoluminal Tracheal Occlusion (FETO) With Smart-TO (Smart-FETO)
Fetoscopic Endoluminal Tracheal Occlusion (FETO) With Smart-TO Device in Fetuses With Congenital Diaphragmatic Hernia and Moderate to Severe Pulmonary Hypoplasia: Proof of Concept and Safety Evaluation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Congenital diaphragmatic hernia (CDH) leads to lung hypoplasia and impaired lung vasculature. Fetal lung growth may be stimulated by fetal endoscopic tracheal occlusion (FETO). In severe CDH, FETO may improve survival. In the moderate cases, the prematurity induced by the plug-unplug strategy limits the benefit from the lung growth induced by tracheal occlusion.
One of the main drawbacks of FETO is the need for in-utero reversal of tracheal occlusion by the balloon, as the current procedure involves re-establishment of patent airways either electively at 34 weeks' gestation or earlier if required, ideally at least 24 h before birth. Unfortunately, removal of the balloon is a difficult, invasive, and risky procedure. Furthermore, it requires a specialist team to be able to reverse the occlusion at all times. As a result, it is recommended that the patient stays close to a FETO center during the whole duration of the occlusion, which may limit the acceptability of FETO.
The Smart-TO balloon allows an easy, remotely controlled, and non-invasive reversal occlusion, so it allows to overcome issues related to the airway reestablishment. The technology solution is based on a magnetic valve that opens under the influence of the peripheral magnetic field around a magnetic resonance (MR) scanner. The opening of the valve induces the deflation of the balloon, which is then washed out by the fluid coming out from the lungs.
The purpose of this study is to make the proof of concept and to evaluate the safety of fetoscopic endoluminal tracheal occlusion (FETO) using Smart-TO device in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia. Secondary objectives include evaluation of prematurity, preterm premature rupture of membranes, lung growth, and survival at discharge in case of FETO with Smart-TO balloon.
FETO with Smart-TO balloon will be performed between 27 and 31wks + 6 days depending on the severity of pulmonary hypoplasia, according to the same technique that is used with the balloon usually used for FETO procedure. The unplug procedure will be performed between 34 and 34wks + 6 days or earlier if required. The patient will be asked to make a peripheral course around the MR scanner in order to open the magnetic valve and induce the deflation of the balloon. Ultrasound scan will be performed before and after the unplug procedure, in order to check the balloon did not deflate spontaneously at the time of the unplug, and to check the balloon deflates thanks to the magnetic fringe field of the MR scan. Expelling of the Smart-TO balloon outside the airways will be check at birth by a thorax X-ray.
Patients will be monitored during the whole duration of the study so serious unexpected or adverse reactions can be recorded.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Clamart, France, 92140
- Hôpital Béclère
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Le Kremlin-Bicêtre, France, 94270
- Hôpital Bicêtre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
Fetal endoscopic tracheal occlusion using the Smart-TO balloon Unplug procedure by peripheral course around the MR scanner
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Deflation of the Smart-TO balloon after exposure to the fringe field of the MRI
Time Frame: Between 34 and 34+6 amenorrhea weeks
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No visualization of the balloon at ultrasound scan
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Between 34 and 34+6 amenorrhea weeks
|
|
Expelling of the Smart-TO balloon outside the airways
Time Frame: At birth
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Thorax X-ray of the neonate
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At birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serious unexpected or adverse reactions
Time Frame: From date of inclusion until discharge date from hospitalization of newborn, up 15 months
|
Adverse reactions monitoring during the whole study duration
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From date of inclusion until discharge date from hospitalization of newborn, up 15 months
|
|
Spontaneous deflation of the balloon
Time Frame: Between the FETO (27amenorrhea weeks) and the unplug procedure (34 amenorrhea weeks)
|
Ultrasound scan
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Between the FETO (27amenorrhea weeks) and the unplug procedure (34 amenorrhea weeks)
|
|
Prematurity
Time Frame: At birth
|
Gestational age at birth
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At birth
|
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Preterm premature rupture of the membranes (PPROM)
Time Frame: from date of inclusion until delivery, up to 37 amenorrhea weeks
|
Event of PPROM and gestational age at PPROM
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from date of inclusion until delivery, up to 37 amenorrhea weeks
|
|
Fetal lung growth
Time Frame: Before the unplug procedure
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O/E LHR measurement
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Before the unplug procedure
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Survival at discharge
Time Frame: From date of inclusion until discharge date from hospitalization of newborn, up to 6 months
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Neonate survival
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From date of inclusion until discharge date from hospitalization of newborn, up to 6 months
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Survival at 6 months of age
Time Frame: 6 months after birth
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Neonate survival
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6 months after birth
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Oxygen dependence
Time Frame: 6 months after birth
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6 months after birth
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Anne-Gael CORDIER, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Study Chair: Nicolas SANANES, MD, PhD, University Hospital, Strasbourg, France
- Principal Investigator: Alexandra BENACHI, MD, PhD, AH-HP
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A02834-35 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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