Diaphragmatic HerniaNCT05354505
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
A study testing Placement of the GOLDBAL2 balloon in people with Diaphragmatic Hernia, run by Vincent Duron at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragmatic Hernia
- What is being tested?
- Placement of the GOLDBAL2 balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center/NewYork-Presbyterian
New York, New York, 10032
Amanda Alonso, MHA, 212-342-0261, aa2974@cumc.columbia.edu
Vincent Duron, MD
About this study
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).
Read the detailed description
Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year. The defect in the fetal diaphragm allows abdominal organs (intestine, stomach, liver, spleen) to migrate into the thorax, hindering normal lung development. The herniated contents place pressure on the developing lungs and this may result in varying degrees of pulmonary hypoplasia and associated pulmonary hypertension; both of which may be lethal. In an attempt to prenatally quantify the impact of the herniated organs on underlying lung development, prognostic tools have been developed. The most widely used prognostic indicator is lung-to-head ratio (LHR) as measured by prenatal ultrasound. The lung contralateral to the diaphragmatic defect is measured in a transverse plane at the level of the four chamber heart and its area is divided by the fetal head circumference (LHR). The LHR is tracked through the pregnancy but seems to be most strongly correlated with outcomes in the early third trimester.
Fetuses with severe CDH have a high risk of mortality. The current standard of care treatment offers postnatal repair, which is associated with overall survival of 71% in all cases. A majority (68%) of fetuses are prenatally diagnosed, and the survival in this cohort is even lower at 65%. The severity of the defect can be measured prenatally by the degree of pulmonary hypoplasia, and the survival drops to below 30% for those with expected lung volumes below 30% of expected. The purpose of the FETO procedure in severe CDH patients is to improve prenatal lung growth in order to potentially increase neonatal survival.
- Conditions
- Diaphragmatic Hernia
- Being tested
- Placement of the GOLDBAL2 balloon
- Keywords
- Fetal Endoscopic Tracheal Occlusion (FETO), Congenital diaphragmatic hernia (CDH)
- Medical subject headings
- Hernia, Diaphragmatic, Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of the GOLDBAL2 balloonDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Placement of the GOLDBAL2 balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 35 weeks
Secondary outcomes (5)
Change in fetal lung volume growth on prenatal MRI
Fetal MRI prior to balloon placement and 2nd fetal MRI at +/- 2 weeks of balloon retrieval will be performed to calculate the difference between the 1st and 2nd MRIs.
Measured: Baseline and up to 37 weeks
Change in fetal lung growth on prenatal ultrasound
Fetal ultrasound before balloon placement and immediately prior to balloon removal will be performed to calculate the different between the 2 ultrasounds.
Measured: Baseline and up to 35 weeks
Gestational age at delivery
Gestational age at delivery will be measured.
Measured: At the time of delivery (up to 40 weeks of gestation)
Total number of maternal complications
Maternal complications will be recorded and reviewed.
Measured: Up to 6 weeks post-delivery
Survival rate post-delivery
Survival rate will be measured at 180 days for those still hospitalized at the time point.
Measured: Up to 180 days post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start28 May 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragmatic HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vincent Duron
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vincent Duron, Columbia University
- Investigators
- Vincent Duron, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354505
- Sponsor's protocol ID
- AAAU1357
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
- ClinicalTrials.gov ID
- NCT05354505
- Acronym / sponsor ID
- AAAU1357
- Conditions
- Diaphragmatic Hernia
- Keywords
- Fetal Endoscopic Tracheal Occlusion (FETO), Congenital diaphragmatic hernia (CDH)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vincent DuronUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year. The defect in the fetal diaphragm allows abdominal organs (intestine, stomach, liver, spleen) to migrate into the thorax, hindering normal lung development. The herniated contents place pressure on the developing lungs and this may result in varying degrees of pulmonary hypoplasia and associated pulmonary hypertension; both of which may be lethal. In an attempt to prenatally quantify the impact of the herniated organs on underlying lung development, prognostic tools have been developed. The most widely used prognostic indicator is lung-to-head ratio (LHR) as measured by prenatal ultrasound. The lung contralateral to the diaphragmatic defect is measured in a transverse plane at the level of the four chamber heart and its area is divided by the fetal head circumference (LHR). The LHR is tracked through the pregnancy but seems to be most strongly correlated with outcomes in the early third trimester.
Fetuses with severe CDH have a high risk of mortality. The current standard of care treatment offers postnatal repair, which is associated with overall survival of 71% in all cases. A majority (68%) of fetuses are prenatally diagnosed, and the survival in this cohort is even lower at 65%. The severity of the defect can be measured prenatally by the degree of pulmonary hypoplasia, and the survival drops to below 30% for those with expected lung volumes below 30% of expected. The purpose of the FETO procedure in severe CDH patients is to improve prenatal lung growth in order to potentially increase neonatal survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Placement of the GOLDBAL2 balloonGOLDBAL2 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
- Bilateral CDH, unilateral CDH with o/e LHR > 25%, or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of the GOLDBAL2 balloonThe 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) | Device | Treatment |
Primary outcome
Total number of subjects with successful placement of the balloon
Time frame: Up to 30 weeks
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Total number of subjects with successful retrieval of the balloon
Time frame: Up to 35 weeks
Success will be defined by retrieval prior to delivery, including safe retrieval during an ex-utero intrapartum therapy (EXIT) procedure.
5 secondary outcomes
Change in fetal lung volume growth on prenatal MRI
Time frame: Baseline and up to 37 weeks
Change in fetal lung growth on prenatal ultrasound
Time frame: Baseline and up to 35 weeks
Gestational age at delivery
Time frame: At the time of delivery (up to 40 weeks of gestation)
Total number of maternal complications
Time frame: Up to 6 weeks post-delivery
Survival rate post-delivery
Time frame: Up to 180 days post-delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Diaphragmatic Hernia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent Duron, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of the GOLDBAL2 balloon in people with Diaphragmatic Hernia, run by Vincent Duron at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Alonso, MHA (212-342-0261, aa2974@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of subjects with successful placement of the balloon (time frame: Up to 30 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.