Prenatal treatment for congenital diaphragmatic hernia using a new device

Non-invasive Removal of the Smart Tracheal Occlusion Device for Fetal Congenital Diaphragmatic Hernia: A Feasibility Study

This study is testing a new device to see if it can help unborn babies with congenital diaphragmatic hernia grow their lungs better and improve their chances of survival.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Locations: 1 site (Leuven)
• Trial ID: NCT05100693 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of the Smart-TO device for fetoscopic endoluminal tracheal occlusion (FETO) in fetuses diagnosed with congenital diaphragmatic hernia (CDH) and moderate to severe pulmonary hypoplasia. The procedure involves the prenatal deflation of the device to stimulate fetal lung growth, which may improve survival rates. The study addresses the challenges associated with traditional balloon removal procedures, which can be invasive and carry risks for both the fetus and mother. By utilizing the Smart-TO device, the researchers hope to simplify the process and enhance outcomes for affected fetuses.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women carrying a fetus with isolated congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia.

Not a fit: Patients with mild congenital diaphragmatic hernia or those not eligible for fetoscopic endoluminal tracheal occlusion will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and lung development in fetuses with congenital diaphragmatic hernia.

How similar studies have performed: Previous studies have shown that fetoscopic endoluminal tracheal occlusion can improve outcomes in severe cases of congenital diaphragmatic hernia, indicating potential for success with this novel device.

Eligibility criteria

Inclusion Criteria:

* Women carrying a fetus with isolated CDH eligible for FETO, i.e. with severe or moderate hypoplasia:

  * Left sided CDH with severe (i.e. quotient of observed-to-expected- lung-to-head ratio under 25%) or moderate pulmonary hypoplasia (observed-to-expected- lung-to-head ratios of 25 to 34.9% (any liver position), or 35 to 44.9% with intrathoracic liver herniation)
  * Right sided CDH with severe pulmonary hypoplasia (quotient of observed-to-expected- lung-to-head ratio under 50%)
* 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:

* History of allergy to latex
* Contraindication to fetoscopy and FETO (maternal diseases or technical limitations making prenatal surgery hazardous or impossible)
* Premature Membrane Rupture (PROM)
* Multiple pregnancy
* Maternal age less than 18 years
* Refusal to stay close to the UZ Leuven until balloon removal
* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
* Participation in another interventional trial with an investigational medicinal product (IMP) or device

Where this trial is running

Leuven

• UZ Leuven — Leuven, Belgium (Recruiting)

Study contacts

• Study coordinator: Jan Depret, PhD, MD

Conditions Congenital Diaphragmatic Hernia