Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) (FETO)

February 19, 2026 updated by: Rodrigo Ruano

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Rodrigo Ruano, M.D.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Terminated
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Latex balloon, with radio-opaque inclusion
Device: Catheter System
100 cm tapered micro-catheter
Other Names:
  • BALTACCIBDPE100

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Up to 34 weeks gestation
Operative time
Time Frame: Up to 34 weeks gestation
FETO placement and release operative times reported in minutes
Up to 34 weeks gestation
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)
Up to 34 weeks gestation
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
Up to 41 weeks gestation
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
Up to 41 weeks gestation
Gestational Age at Delivery
Time Frame: Up to 41 weeks gestation
Gestation Age reported at time of delivery
Up to 41 weeks gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fetal Lung Growth as measured via Fetal Lung Volume
Time Frame: Up to 41 weeks gestation
Fetal Lung Volume as measured via ultrasound
Up to 41 weeks gestation
Fetal Lung Growth as measured via LHR
Time Frame: Up to 41 weeks gestation
Lung area to head circumference Ratio (LHR) as measured via ultrasound
Up to 41 weeks gestation
Fetal survival
Time Frame: Up to 24 months post partum
Fetal survival reported in days
Up to 24 months post partum
Number of newborns reported at each oxygen dependency grading
Time Frame: Up to 24 months post partum
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Up to 24 months post partum
Number of occurrence of severe pulmonary hypertension
Time Frame: Up to 24 months post partum
Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram
Up to 24 months post partum
Number of infants requiring ECMO Support
Time Frame: Up to 24 months post partum
Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support
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 infant was in the neonatal intensive care unit
Up to 24 months post partum
Number of days of ventilator support
Time Frame: Up to 24 months post partum
Number of reported days infants required ventilator support
Up to 24 months post partum
Number of days of maternal hospitalization
Time Frame: Up to 24 months post partum
Number of reported days of maternal hospitalization
Up to 24 months post partum
Number of infants reporting presence of complications
Time Frame: Up to 24 months post partum
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
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 infants reported to require the use of patch or muscle flap
Up to 24 months post partum
Number of participants at each route of delivery
Time Frame: Day 1 (post partum)
Number of participants that delivered vaginally and via caesarean section
Day 1 (post partum)
Number of days of Diaphragmatic Repair
Time Frame: Up to 24 months post partum
Number of days of infant Diaphragmatic Repair
Up to 24 months post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rodrigo Ruano

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rodrigo Ruano, M.D., Ph.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20220033-1
  • 16-008720 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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