Severe Congenital Diaphragmatic HerniaNCT07767825
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe CDH
A study testing Goldballoon Detachable Balloon (GOLDBAL2) in people with Severe Congenital Diaphragmatic Hernia, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Severe Congenital Diaphragmatic Hernia
- What is being tested?
- Goldballoon Detachable Balloon (GOLDBAL2)
- 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
- Sep 2026to Sep 2031
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of a signed and dated informed consent form
- Pregnant individuals age 18 years and older
- Singleton pregnancy
- A normal karyotype with confirmation by culture results, CMA with non-pathologic variants, whole exome or genome sequencing (WES or WGS).
- Isolated left CDH with severe pulmonary hypoplasia with o/e LHR less than 25% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)
- Isolated right CDH with severe pulmonary hypoplasia with o/e LHR equal or less than 30% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)
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- Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Willing to reside within a 30-minute distance of the NYULH in the time period between the FETO placement procedure and the balloon retrieval procedure, and ability to maintain follow-up appointments
- The subject has a support person (e.g., spouse, partner, friend, parent) who is available to stay with her for the duration of the pregnancy near NYULH.
- Willing to comply with restrictions of daily living, including inability to exercise, have intercourse, or return to work
- Meets psychosocial criteria
Who cannot join
- Natural rubber latex allergy
- Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI or echocardiogram at the fetal treatment center.
- Signs of preterm labor, cervix shortened to ≤20 mm at enrollment or at 24 hours prior to FETO balloon insertion procedure) or a uterine anomaly strongly predisposing to preterm labor.
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accreta, chorioangioma) known at time of enrollment
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- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- There is no safe or technically feasible fetoscopic approach to balloon placement
- Participation in another intervention study that influences maternal and fetal morbidity and mortality
- Any other condition which, in the opinion of the investigator, would compromise safety, feasibility or impede compliance.
- Bilateral CDH, isolated left sided CDH with o/e LHR >/= 25% and isolated right sided CDH >30%
- No intrathoracic liver herniation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia (CDH)
The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34 weeks and 6 days of gestation. The primary endpoint is successful placement and removal of the balloon.
- Conditions
- Severe Congenital Diaphragmatic Hernia
- Being tested
- Goldballoon Detachable Balloon (GOLDBAL2)
- 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.
Goldballoon Detachable Balloon (GOLDBAL2)Device
GOLDBAL2 will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100).
| Study group | Role | What they receive |
|---|---|---|
| Congenital diaphragmatic hernia (CDH) | Experimental | FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34weeks and 6 days of gestation. Receives: Device: Goldballoon Detachable Balloon (GOLDBAL2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful balloon placements at age 27w0d - 29w6d and removal at 34 weeks of gestation
Measured: Up to 35 weeks
Secondary outcomes (1)
Difference between the relative lung volume (o/e LHR and o/e TLV)
Fetal lung growth will be calculated by the difference between the relative lung volume (observed-to-expected (o/e) lung-to-head ratio (LHR) and o/e total lung volume (TLV)) measured before and after FETO
Measured: Baseline, removal of balloon (up to 35 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose L. Peiro, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767825
- Sponsor's protocol ID
- 26-00182
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: jose.peiro@nyulangone.org. Besides the study publications, by FDA regulation, the data will be shared with the NAFTNet FETO registry, which will involve all of the individual participant data collected during the trial, after deidentification. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia (CDH)
- ClinicalTrials.gov ID
- NCT07767825
- Acronym / sponsor ID
- 26-00182
- Conditions
- Severe Congenital Diaphragmatic Hernia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 17 Aug 2026 (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 this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34 weeks and 6 days of gestation. The primary endpoint is successful placement and removal of the balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital diaphragmatic hernia (CDH) | Experimental | Device: Goldballoon Detachable Balloon (GOLDBAL2)FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34weeks and 6 days of gestation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of a signed and dated informed consent form
- Pregnant individuals age 18 years and older
- Singleton pregnancy
- A normal karyotype with confirmation by culture results, CMA with non-pathologic variants, whole exome or genome sequencing (WES or WGS).
- Isolated left CDH with severe pulmonary hypoplasia with o/e LHR less than 25% with liver up (measured at 18 weeks 0 days to 29 weeks 5 days of gestation)
Key exclusion criteria (14 listed)
- Natural rubber latex allergy
- Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI or echocardiogram at the fetal treatment center.
- Signs of preterm labor, cervix shortened to ≤20 mm at enrollment or at 24 hours prior to FETO balloon insertion procedure) or a uterine anomaly strongly predisposing to preterm labor.
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
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 |
|---|---|---|
| Goldballoon Detachable Balloon (GOLDBAL2)GOLDBAL2 will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100). | Device | Congenital diaphragmatic hernia (CDH) |
Primary outcome
Number of successful balloon placements at age 27w0d - 29w6d and removal at 34 weeks of gestation
Time frame: Up to 35 weeks
1 secondary outcome
Difference between the relative lung volume (o/e LHR and o/e TLV)
Time frame: Baseline, removal of balloon (up to 35 weeks)
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 17 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: jose.peiro@nyulangone.org. Besides the study publications, by FDA regulation, the data will be shared with the NAFTNet FETO registry, which will involve all of the individual participant data collected during the trial, after deidentification. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Jose L. Peiro, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goldballoon Detachable Balloon (GOLDBAL2) in people with Severe Congenital Diaphragmatic Hernia, run by NYU Langone Health 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: opening soon, as of the sponsor's last update on 17 Aug 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 Erin Lonergan, MHA, BSN, RN (212-814-4261, Erin.lonergan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful balloon placements at age 27w0d - 29w6d and removal at 34 weeks of gestation (time frame: Up to 35 weeks). 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 17 Aug 2026.