Congenital Diaphragmatic HerniaFETONCT05461222
Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
A study testing Balt "Goldballoon" in people with Congenital Diaphragmatic Hernia, run by Yair Blumenfeld at 1 site in United States.
Trial summary
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea)… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Balt "Goldballoon"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 31 Aug 2030
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal Age: 18-50
- Singleton gestation
- Gestational age before 29 weeks 6 days
- Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms.
- Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
- Absence of associated fetal structural cardiac anomalies by a dedicated fetal echocardiogram
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- Absence of other structural anomalies by ultrasound or MRI
- Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT).
- Must be willing to remain near LPCH Stanford (within 30 minutes from the hospital) for the duration of the balloon placement.
- No maternal and/or fetal contra-indications to fetal surgery such as a bleeding disorder, poorly controlled diabetes or hypertension, short cervix (measuring < 20mm), risk for preterm birth etc.
- Planned pregnancy surveillance at LPCH Stanford
- Planned delivery at LPCH Stanford
- Able to provide written consent
- Willingness to comply with all study procedures and availability (meets psychosocial criteria) for the duration of the study including having a support person
Who cannot join
- Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder
- High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring < 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring cerclage)
- Non-isolated CDH - CDH with additional structural anomalies
- Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight
- History of natural rubber latex allergy
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
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- Participation in another intervention study that influences maternal and fetal morbidity and mortality.
- Bilateral CDH, left-sided CDH with O/E LHR >25%, or left-sided CDH with O/E LHR <25% but liver completely down in abdomen
- Right-sided CDH O/E LHR >30% or right-sided CDH with O/E LHR <30% with liver completely down in abdomen
- Significant placental abnormalities (abruption, chorioangioma, accreta) known at the time of enrollment and/or surgery
- Maternal-fetal Rhesus 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.
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
Lucile Packard Children's Hospital
Stanford, California, 94305-6070
Kathryn Batham, 6507247826, mfmresearch@stanford.edu
About this study
Official title: A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Balt "Goldballoon"
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balt "Goldballoon"Device
Fetal endoscopic tracheal occlusion (FETO) is a procedure where a balloon is placed in the main airway or "windpipe" of the fetus, to help with the development of the lungs. This is performed using a fetoscope, a small camera that is inserted into the amniotic cavity and deploying the FETO Goldballoon into the fetal trachea.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Endoscopic Tracheal Occlusion (FETO) | Experimental | FETO is performed in-utero and the balloon is removed prior to delivery, and children will have follow-up visits until the age of 2 Receives: Device: Balt "Goldballoon" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neonates who survive until initial hospital discharge
Measured: Average approximately 6 months (up to 1 year)
Secondary outcomes (5)
Number of neonates who survive until 28 days of life
Measured: 28 days
Number of children who survive until 6 months of age
Measured: 6 months
Number of children who survive until 1 year of age
Measured: 1 year
Number of children who survive until 2 years of age
Measured: 2 years
Number of children who receive extracorporeal membrane oxygenation (ECMO)
Measured: Average approximately 6 months (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start17 Apr 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yair Blumenfeld
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yair Blumenfeld, Stanford University
- Investigators
- Yair Blumenfeld, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461222
- Sponsor's protocol ID
- 63230
- Acronym
- FETO
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2022
- Last updated
- 29 Jan 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effectiveness of Fetal Endoscopic Tracheal Occlusion (FETO) in the Management of Severe Prenatally Diagnosed Congenital Diaphragmatic Hernia (CDH)
- ClinicalTrials.gov ID
- NCT05461222
- Acronym / sponsor ID
- FETO / 63230
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Yair BlumenfeldUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 18 Jul 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.
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Endoscopic Tracheal Occlusion (FETO) | Experimental | Device: Balt "Goldballoon"FETO is performed in-utero and the balloon is removed prior to delivery, and children will have follow-up visits until the age of 2 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Maternal Age: 18-50
- Singleton gestation
- Gestational age before 29 weeks 6 days
- Severe left or right-sided CDH: For severe left sided CDH observed-to-expected lung-to- head ratio (o/e LHR) less than 25% between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms. For severe right sided CDH o/e LHR less than 30 % between 22 and 29 6/7 weeks' gestation, liver herniation, MRI lung volumes less than 30% expected based on gestational age nomograms.
- Normal genetic karyotype or microarray testing by amniocentesis or chorionic villus sampling (CVS)
Key exclusion criteria (13 listed)
- Contraindications to fetal surgery including poorly controlled hypertension, diabetes or other maternal medical condition including hematological disorder
- High risk for preterm labor and/or delivery based on either significant history of preterm birth, short cervix (measuring < 20mm), significant uterine anomaly or other risk factor, incompetent cervix (requiring cerclage)
- Non-isolated CDH - CDH with additional structural anomalies
- Significant maternal obesity defined as a body mass index (BMI) greater than 40. BMI is a calculation which includes a person's height and weight
- History of natural rubber latex allergy
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 |
|---|---|---|
| Balt "Goldballoon"Fetal endoscopic tracheal occlusion (FETO) is a procedure where a balloon is placed in the main airway or "windpipe" of the fetus, to help with the development of the lungs. This is performed using a fetoscope, a small camera that is inserted into the amniotic cavity and deploying the FETO Goldballoon into the fetal trachea. | Device | Fetal Endoscopic Tracheal Occlusion (FETO) |
Primary outcome
Number of neonates who survive until initial hospital discharge
Time frame: Average approximately 6 months (up to 1 year)
5 secondary outcomes
Number of neonates who survive until 28 days of life
Time frame: 28 days
Number of children who survive until 6 months of age
Time frame: 6 months
Number of children who survive until 1 year of age
Time frame: 1 year
Number of children who survive until 2 years of age
Time frame: 2 years
Number of children who receive extracorporeal membrane oxygenation (ECMO)
Time frame: Average approximately 6 months (up to 1 year)
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 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Yair Blumenfeld, MD principal investigator
Stanford 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 Balt "Goldballoon" in people with Congenital Diaphragmatic Hernia, run by Yair Blumenfeld 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 14 inclusion and 13 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 Jan 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonates who survive until initial hospital discharge (time frame: Average approximately 6 months (up to 1 year)). 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 Jan 2026.