Recruiting

Fetoscopic Endoluminal Tracheal Occlusion

Sponsor:

Rodrigo Ruano

Code:

NCT03138863

Conditions

Congenital Diaphragmatic Hernia

Pulmonary Hypoplasia

Pulmonary Artery Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

BALT GoldbBAL2 Detachable Balloon

Catheter System

Study Details

Brief 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).

Conditions

Congenital Diaphragmatic Hernia

Pulmonary Hypoplasia

Pulmonary Artery Hypertension

Study ID

NCT03138863

Start date

May 1, 2024

Status verified date

Feb, 2026

Completion date

Nov 1, 2030

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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:

  • 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 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

BALT GoldbBAL2 Detachable Balloon

Latex balloon, with radio-opaque inclusion

Catheter System

100 cm tapered micro-catheter

Primary outcome measure

  • Number of successfully completed FETO procedures [ Time Frame: Up to 34 weeks gestation ]
  • Operative time [ Time Frame: Up to 34 weeks gestation ]
  • Frequency of unplanned balloon removal [ Time Frame: Up to 34 weeks gestation ]
  • Number of incidences of maternal complications [ Time Frame: Up to 41 weeks gestation ]
  • Number of participants with maternal complications [ Time Frame: Up to 41 weeks gestation ]
  • Gestational Age at Delivery [ Time Frame: Up to 41 weeks gestation ]

Central Contacts and Locations

Central contacts

Rodrigo A Ruano, MD, Ph.D

305.689.8001rodrigo.ruano@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Rodrigo Ruano, MD, Ph.D

305-689-8001rodrigo.ruano@miami.edu

Principal Investigator:

Rodrigo Ruano, M.D.

More Information

Sponsor

Rodrigo Ruano

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rodrigo Ruano on 2026-02-23.