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The purpose of this study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia.
Full description
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by impaired closure of the diaphragm. This enables abdominal viscera to herniate into the thoracic cavity, leading to hypoplastic lungs and impaired lung vasculature. Fetal lung growth may be stimulated by Fetoscopic Endoluminal Tracheal Occlusion (FETO). For left-sided CDH, there is now level I evidence that it significantly improves survival in severe cases; the effect in moderate cases is much less.
Despite its benefits, the current procedure has many disadvantages. First, there is the need for prenatal reversal of the balloon, which is invasive. In utero balloon removal re-establishes airway patency. This can be done electively at 34 weeks or earlier if required, but preferentially at least 24 hours before birth. "Unplugging" requires a second procedure and a specialist team familiar with the procedure, which is available at all times. In the most extensive series published thus far, 28% of balloon removals were in an emergency setting. The only neonatal deaths were caused by complications when balloon reversal was attempted in centers without experience or unprepared. In utero reversal of the occlusion is also an invasive procedure because it requires ultrasound-guided puncture or fetoscopy. The second procedure adds both to the fetal and maternal risks.
The Smart-TO balloon allows remotely controlled non-invasive reversal of the occlusion. Around the balloon neck, there is a metallic cylinder and inside a magnetic ball, which acts as a valve. Deflation occurs under a strong magnetic field, as generated by a clinical MRI machine. For that, it is sufficient for the pregnant woman to walk around a clinical MRI machine. 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 investigators have completed the translational research that proved the safety and efficacy of this balloon for FETO and want to use this medical device for the first time in humans. The purpose of this first in-woman study is to demonstrate the ability to prenatally deflate and to evaluate the safety of the Smart-TO device for FETO in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia. Secondary outcomes include safety parameters.
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 used with the balloon usually used for the FETO procedure. Reversal of the tracheal occlusion will be performed between 34 and 34wks + 6 days or earlier if necessary. In the unlikely event of a patient with imminent signs of delivery, balloon removal will be done on placental circulation or postnatally. This will ensure the patient's safety. The patient will be asked to walk around the MR scanner to open the magnetic valve and induce the deflation of the balloon. Afterwards, an ultrasound will be performed by two experienced sonographers to assess balloon deflation. In the case of deflation failure, a second and -if necessary- a third MRI exposure will be attempted following ultrasound confirmation to ensure balloon deflation. In the case of balloon failure to deflate or any doubt about deflation, an MRI with image acquisition will be performed to (1) attempt deflation and (2) assess the airway patency. In the case of failure to deflate, balloon removal will be done by fetoscopy, placental circulation, or postnatally (depending on the clinical scenario). Within 24 hours after balloon deflation:
An MRI (with image acquisition) will be performed to locate the deflated balloon and as a second safety measure to ensure the patency of the airways.
The patient will be allowed to return to her tertiary centre of preference once the airways' patency is confirmed.
Delivery does not differ from the standard care protocol for children with CDH. In the case of MRI deflation protocol, the following will be done to locate the balloon:
The follow-up and management of the newborn will be according to the standardized management protocol of the CDH EURO Consortium. Data collection will be stopped at the moment the child is discharged from the hospital.
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Inclusion criteria
Women carrying a fetus with isolated CDH eligible for FETO, i.e. with severe or moderate hypoplasia:
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
Maternal age of 18 years or older
Single pregnancy
Signed informed consent
Consent to have an ultrasound of the uterus after delivery when indicated
Postnatal management center agrees to participate
Exclusion criteria
Participants eligible for this Trial must not meet any of the following criteria:
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25 participants in 1 patient group
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Central trial contact
Jan Depret, PhD, MD; David Basurto, MD
Data sourced from clinicaltrials.gov
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