Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)

NCT05354505 | Recruiting DMC FDA Device

• 1 other identifier: AAAU1357
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).

Conditions

Diaphragmatic Hernia

Keywords

Fetal Endoscopic Tracheal Occlusion (FETO); Congenital diaphragmatic hernia (CDH)

Outcome Measures

Primary Outcomes (2)

• Total number of subjects with successful placement of the balloon

  Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.

  Up to 30 weeks

• Total number of subjects with successful retrieval of the balloon

  Success will be defined by retrieval prior to delivery, including safe retrieval during an ex-utero intrapartum therapy (EXIT) procedure.

  Up to 35 weeks

Secondary Outcomes (5)

• Change in fetal lung volume growth on prenatal MRI

  Baseline and up to 37 weeks

• Change in fetal lung growth on prenatal ultrasound

  Baseline and up to 35 weeks

• Gestational age at delivery

  At the time of delivery (up to 40 weeks of gestation)

• Total number of maternal complications

  Up to 6 weeks post-delivery

• Survival rate post-delivery

  Up to 180 days post-delivery

Study Arms (1)

Treatment

EXPERIMENTAL

GOLDBAL2 balloon will be placed for Fetus diagnosed with Congenital diaphragmatic hernia (CDH) at Gestational age of 27w0d - 29w6d and retrieved at Gestational age of 34w0d to 34w 6 days

Device: Placement of the GOLDBAL2 balloon

Interventions

Placement of the GOLDBAL2 balloon DEVICE

The Fetal Endoscopic Tracheal Occlusion (FETO) procedure using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) will be used to treat fetuses diagnosed with severe Congenital Diaphragmatic Hernia (CDH)

Treatment

Eligibility Criteria

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

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
• Pregnant women, age 18 years and older
• Singleton pregnancy
• No pathogenic variants on microarray or pathologic findings on karyotype; results by fluorescence in situ hybridization (FISH) will be acceptable if patient is \>26 weeks
• Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
• Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR \<25% with liver up
• Gestational age at FETO procedure: if o/e LHR \<25%, will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
• Meets psychosocial criteria
• Willing to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) and ability to maintain follow up appointments. NYP/CUIMC will work with the study participant to assist in securing housing 30 minutes from the hospital if this is a challenge to her.
• Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC)
• Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

You may not qualify if:

• Multi-fetal pregnancy
• History of latex allergy
• History of preterm labor or incompetent cervix (requiring cerclage), short cervix (\<20mm), or uterine anomaly predisposing to preterm labor
• Psychosocial ineligibility
• Inability to reside within 30 minutes of NewYork-Presbyterian Sloane Hospital for Women/Columbia University Irving Medical Center (CUIMC) or inability to maintain follow up appointments
• Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
• Bilateral CDH, unilateral CDH with o/e LHR \> 25%, or unilateral CDH with o/e LHR \<25% but liver completely down in abdomen
• Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
• Maternal contraindications to elective fetoscopic surgery
• Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
• No safe or feasible fetoscopic approach to balloon placement
• Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
• Participation in another intervention study that influences maternal and fetal morbidity and mortality.

Sponsors & Collaborators

• Vincent Duron: lead

Study Sites (1)

Columbia University Irving Medical Center/NewYork-Presbyterian

New York, New York, 11021, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Diaphragmatic; Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincent Duron, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Alonso, MHA

CONTACT

212-342-0261; aa2974@cumc.columbia.edu

Study Design

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

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)