Smart Removal for Congenital Diaphragmatic Hernia

NCT05100693 | Recruiting DMC

• 1 other identifier: S65423
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (1)

• To demonstrate the ability to prenatally deflate the Smart-TO balloon by the magnetic fringe field generated by an MRI scanner

  • Deflation rate after MRI exposure, assessed through ultrasound (US) immediately after MRI exposure

  Up to 34+6 weeks of pregnancy

Secondary Outcomes (5)

• Balloon expulsion from the fetal airways after deflation.

  Immediately after MRI exposure

• Rate of spontaneous deflation of the balloon.

  Up to 34+6 weeks of pregnancy

• Percentage of lung growth

  Two weeks after FETO

• Number of adverse events related to the balloon.

  From date of inclusion until date of discharge from the hospital

• Balloon localisation at birth

  At birth

Study Arms (1)

Procedure FETO with the Smart-TO balloon

EXPERIMENTAL

Fetal endoscopic tracheal occlusion using the Smart-TO balloon. Balloon removal procedure by peripheral course around the MR scanner

Other: Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloon

Interventions

Fetoscopic Endoluminal Tracheal Occlusion with the Smart-TO Balloon OTHER

Fetal Endoscopic Tracheal Occlusion using the Smart-TO balloon and non-invasive balloon removal by the peripheral magnetic field of an magnetic resonance scanner.

Also known as: FETO

Procedure FETO with the Smart-TO balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jan Depret, PhD, MD

CONTACT

+3216345123; jan.deprest@uzleuven.be

David Basurto, MD

CONTACT

+3216341974; david.basurto@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 29, 2021
• Study Start: September 8, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)