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RecruitingNCT03138863FETOUpdated Feb 23, 2026

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

An interventional study of BALT GoldbBAL2 Detachable Balloon and Catheter System in Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia and Pulmonary Artery Hypertension, sponsored by Rodrigo Ruano. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Rodrigo Ruano · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Congenital Diaphragmatic Hernia
  • Pulmonary Hypoplasia
  • Pulmonary Artery Hypertension

Keywords

  • fetal lungs
  • fetal surgery
  • congenital diaphragmatic hernia
  • tracheal occlusion
  • pulmonary hypoplasia
03

In context

Hernias, Diaphragmatic, Congenital

86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.

This study's planned enrollment of 10 is below the median of 30 across 62 interventional studies indexed under Hernias, Diaphragmatic, Congenital.

Browse Hernias, Diaphragmatic, Congenital studies →

Lead sponsor

Rodrigo Ruano is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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 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 , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    FETO Group

    Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.

    Device: BALT GoldbBAL2 Detachable Balloon · Device: Catheter System

Interventions

  • DeviceBALT GoldbBAL2 Detachable Balloon

    Latex balloon, with radio-opaque inclusion

  • DeviceCatheter System

    100 cm tapered micro-catheter

    Also known as: BALTACCIBDPE100

06

What researchers measure

Primary outcomes

  1. Number of successfully completed FETO procedures

    The number of successful placement and removal of balloon during FETO procedure

    Time frame: Up to 34 weeks gestation

  2. Operative time

    FETO placement and release operative times reported in minutes

    Time frame: Up to 34 weeks gestation

  3. Frequency of unplanned balloon removal

    The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)

    Time frame: Up to 34 weeks gestation

  4. Number of incidences of maternal complications

    Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

    Time frame: Up to 41 weeks gestation

  5. Number of participants with maternal complications

    Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

    Time frame: Up to 41 weeks gestation

  6. Gestational Age at Delivery

    Gestation Age reported at time of delivery

    Time frame: Up to 41 weeks gestation

Secondary outcomes

  1. Fetal Lung Growth as measured via Fetal Lung Volume

    Fetal Lung Volume as measured via ultrasound

    Time frame: Up to 41 weeks gestation

  2. Fetal Lung Growth as measured via LHR

    Lung area to head circumference Ratio (LHR) as measured via ultrasound

    Time frame: Up to 41 weeks gestation

  3. Fetal survival

    Fetal survival reported in days

    Time frame: Up to 24 months post partum

  4. Number of newborns reported at each oxygen dependency grading

    Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician

    Time frame: Up to 24 months post partum

  5. Number of occurrence of severe pulmonary hypertension

    Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram

    Time frame: Up to 24 months post partum

  6. Number of infants requiring ECMO Support

    Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support

    Time frame: Up to 24 months post partum

  7. Number of days in neonatal intensive care unit

    Number of days infant was in the neonatal intensive care unit

    Time frame: Up to 24 months post partum

  8. Number of days of ventilator support

    Number of reported days infants required ventilator support

    Time frame: Up to 24 months post partum

  9. Number of days of maternal hospitalization

    Number of reported days of maternal hospitalization

    Time frame: Up to 24 months post partum

  10. 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

    Time frame: Up to 24 months post partum

  11. Number of infants requiring the use of patch or muscle flap

    Number of infants reported to require the use of patch or muscle flap

    Time frame: Up to 24 months post partum

  12. Number of participants at each route of delivery

    Number of participants that delivered vaginally and via caesarean section

    Time frame: Day 1 (post partum)

  13. Number of days of Diaphragmatic Repair

    Number of days of infant Diaphragmatic Repair

    Time frame: Up to 24 months post partum

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Dec 2027, 43 months after the start.

Of 40 interventional studies with no phase under Hernias, Diaphragmatic, Congenital, half reached primary completion within 108 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 133. This study's planned 43 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2017
First posted
May 3, 2017
StartActual
May 1, 2024
Primary completionEst.
Dec 1, 2027
CompletionEst.
Nov 1, 2030
Last update
Feb 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03138863
Lead sponsor
Rodrigo Ruano
Responsible party
Rodrigo Ruano (Professor and Chief of MFM Division, University of Miami) — Sponsor-investigator
First posted
May 3, 2017
Start date
May 1, 2024
Primary completion
Dec 1, 2027 (estimated)
Completion
Nov 1, 2030 (estimated)
Last update
Feb 23, 2026

Study contacts

Rodrigo A Ruano, MD, Ph.D
Contact
rodrigo.ruano@miami.edu
305.689.8001
Rodrigo Ruano, M.D., Ph.D.
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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