Congenital Diaphragmatic HerniaFETONCT03138863
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
A study testing BALT GoldbBAL2 Detachable Balloon and Catheter System in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Rodrigo Ruano at 2 sites in United States.
Trial summary
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Artery Hypertension
- What is being tested?
- BALT GoldbBAL2 Detachable Balloon and Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2024to 1 Nov 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
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks.
- Isolated Left CDH with liver up
- Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery.
- Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
- Patient meets psychosocial criteria
Who cannot join
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
- Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
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- Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accrete) known at time of enrollment
- 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
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Rodrigo Ruano, MD, Ph.D, 305-689-8001, rodrigo.ruano@miami.edu
Rodrigo Ruano, M.D.
- Terminated
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
- Being tested
- BALT GoldbBAL2 Detachable Balloon, Catheter System
- Keywords
- fetal lungs, fetal surgery, congenital diaphragmatic hernia, tracheal occlusion, pulmonary hypoplasia
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALT GoldbBAL2 Detachable BalloonDevice
Latex balloon, with radio-opaque inclusion
Catheter SystemDevice
Also called BALTACCIBDPE100
100 cm tapered micro-catheter
| Study group | Role | What they receive |
|---|---|---|
| FETO Group | Experimental | Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system. Receives: Device: BALT GoldbBAL2 Detachable Balloon; Device: Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successfully completed FETO procedures
The number of successful placement and removal of balloon during FETO procedure
Measured: Up to 34 weeks gestation
Operative time
FETO placement and release operative times reported in minutes
Measured: Up to 34 weeks gestation
Frequency of unplanned balloon removal
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Measured: Up to 34 weeks gestation
Number of incidences of maternal complications
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Measured: Up to 41 weeks gestation
Number of participants with maternal complications
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Measured: Up to 41 weeks gestation
Gestational Age at Delivery
Gestation Age reported at time of delivery
Measured: Up to 41 weeks gestation
Secondary outcomes (13)
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Volume as measured via ultrasound
Measured: Up to 41 weeks gestation
Fetal Lung Growth as measured via LHR
Lung area to head circumference Ratio (LHR) as measured via ultrasound
Measured: Up to 41 weeks gestation
Fetal survival
Fetal survival reported in days
Measured: Up to 24 months post partum
Number of newborns reported at each oxygen dependency grading
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Measured: Up to 24 months post partum
Number of occurrence of severe pulmonary hypertension
Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram
Measured: Up to 24 months post partum
Number of infants requiring ECMO Support
Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support
Measured: Up to 24 months post partum
Number of days in neonatal intensive care unit
Number of days infant was in the neonatal intensive care unit
Measured: Up to 24 months post partum
Number of days of ventilator support
Number of reported days infants required ventilator support
Measured: Up to 24 months post partum
Number of days of maternal hospitalization
Number of reported days of maternal hospitalization
Measured: Up to 24 months post partum
Number of infants reporting presence of complications
Number of infants reporting the presence of: periventricular leucomalacia at < 2 months postnatally, neonatal sepsis, intraventricular hemorrhage (grade 0-III), retinopathy of prematurity (grade III or higher), gastro-esophageal reflux, tracheomegaly and tracheomalacia
Measured: Up to 24 months post partum
Number of infants requiring the use of patch or muscle flap
Number of infants reported to require the use of patch or muscle flap
Measured: Up to 24 months post partum
Number of participants at each route of delivery
Number of participants that delivered vaginally and via caesarean section
Measured: Day 1 (post partum)
Number of days of Diaphragmatic Repair
Number of days of infant Diaphragmatic Repair
Measured: Up to 24 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start1 May 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Nov 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rodrigo Ruano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rodrigo Ruano, University of Miami
- Investigators
- Rodrigo Ruano, M.D., Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138863
- Sponsor's protocol ID
- 20220033-1
- Other IDs
- 16-008720
- Acronym
- FETO
- Status last verified
- Feb 2026
- First submitted
- 1 May 2017
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
- ClinicalTrials.gov ID
- NCT03138863
- Acronym / sponsor ID
- FETO / 20220033-1
- Keywords
- fetal lungs, fetal surgery, congenital diaphragmatic hernia, tracheal occlusion, pulmonary hypoplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rodrigo RuanoUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 3 May 2017 (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 research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FETO Group | Experimental | Device: BALT GoldbBAL2 Detachable Balloon, Device: Catheter SystemParticipants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks.
- Isolated Left CDH with liver up
- Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery.
- Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
Key exclusion criteria (14 listed)
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
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 GoldbBAL2 Detachable BalloonLatex balloon, with radio-opaque inclusion | Device | FETO Group |
| Catheter SystemAlso: BALTACCIBDPE100100 cm tapered micro-catheter | Device | FETO Group |
Primary outcome
Number of successfully completed FETO procedures
Time frame: Up to 34 weeks gestation
The number of successful placement and removal of balloon during FETO procedure
Operative time
Time frame: Up to 34 weeks gestation
FETO placement and release operative times reported in minutes
Frequency of unplanned balloon removal
Time frame: Up to 34 weeks gestation
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Number of incidences of maternal complications
Time frame: Up to 41 weeks gestation
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Number of participants with maternal complications
Time frame: Up to 41 weeks gestation
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Gestational Age at Delivery
Time frame: Up to 41 weeks gestation
Gestation Age reported at time of delivery
13 secondary outcomes
Fetal Lung Growth as measured via Fetal Lung Volume
Time frame: Up to 41 weeks gestation
Fetal Lung Growth as measured via LHR
Time frame: Up to 41 weeks gestation
Fetal survival
Time frame: Up to 24 months post partum
Number of newborns reported at each oxygen dependency grading
Time frame: Up to 24 months post partum
Number of occurrence of severe pulmonary hypertension
Time frame: Up to 24 months post partum
Number of infants requiring ECMO Support
Time frame: Up to 24 months post partum
Number of days in neonatal intensive care unit
Time frame: Up to 24 months post partum
Number of days of ventilator support
Time frame: Up to 24 months post partum
Number of days of maternal hospitalization
Time frame: Up to 24 months post partum
Number of infants reporting presence of complications
Time frame: Up to 24 months post partum
Number of infants requiring the use of patch or muscle flap
Time frame: Up to 24 months post partum
Number of participants at each route of delivery
Time frame: Day 1 (post partum)
Number of days of Diaphragmatic Repair
Time frame: Up to 24 months post partum
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 23 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Congenital 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
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
Congenital Diaphragmatic Hernia
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.
Rodrigo Ruano, M.D., Ph.D. principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALT GoldbBAL2 Detachable Balloon and Catheter System in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Rodrigo Ruano at 2 sites 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 6 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 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rodrigo A Ruano, MD, Ph.D (305.689.8001, rodrigo.ruano@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successfully completed FETO procedures (time frame: Up to 34 weeks gestation). The study lists 6 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 23 Feb 2026.