Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)

NCT07577414 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HUM00265099
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if babies with left or right-sided CDH that undergo the FETO procedure survive more often and have fewer long-term complications than babies that have similar left or right-sided CDH that elect not to have the FETO procedure performed during pregnancy.

Conditions

Congenital Diaphragmatic Hernia

Keywords

Pregnant; Fetal Endoscopic tracheal occlusion; Standard of Care arm; Goldballoon Detachable Balloon (GOLDBAL2)

Outcome Measures

Primary Outcomes (5)

• Compare neonatal survival to discharge in LCDH

  6-12 months (birth to discharge)

• Compare neonatal survival to discharge in RCDH

  6-12 months (birth to discharge)

• Number of successful placements the of FETO balloon Gestational age of 27 weeks 0 days gestation to 29 weeks 6 days gestation

  27weeks 0 days gestation to 29 weeks 6 days gestation

• Number of successful retrievals/puncture of the FETO balloon Gestational age of 33 weeks 0 days to 35 weeks 0 days

  Removal prior to delivery at approximately 34 weeks of gestation

• Number of FETO procedure complications

  FETO procedure complications include: Failure of the FETO insertion procedure; FETO device dislodgement potentially requiring a second FETO insertion; Fetal intraoperative injury; Procedural hemorrhage: Bleeding from insertion site or Abruptions; Post-procedural hemorrhage; Preterm premature rupture of membranes; Preterm delivery; Chorioamnion separation; Chorioamnionitis; Polyhydramnios; Oligohydramnios; Emergent removal due to obstetrical complication; Failed percutaneous or fetoscopic removal requiring cesarean section or Ex-Utero Intrapartum Therapy(EXIT) procedure for removal; Neonatal death due to asphyxia if delivery before FETO removal; Non-reassuring fetal heart rate monitoring.

  Balloon placement to delivery (27 weeks up to delivery approximately 40 weeks)

Secondary Outcomes (16)

• Fetal lung growth difference on MRI via o/e Total Fetal Lung Volume (TFLV) (FETO Intervention Arm)

  Baseline (prior to balloon placement) and approximately 2 weeks after balloon retrieval

• Fetal lung growth difference based on prenatal ultrasound via o/e LHR (Both Arms)

  Baseline (prior to balloon placement) and immediately prior to balloon removal and SOC arm 29 + 1 week and 34 +1 week

• Long-term outcome measure infant survival rate

  After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age

• Presence of pulmonary hypertension

  After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age

• Presence of need for supplemental oxygen

  After birth at 6,12, 18, and 24 months (+ 2 months) of corrected age

Study Arms (2)

FETO surgery Intervention Arm

EXPERIMENTAL

Eligible participants that choose the FETO Intervention Arm, will undergo two surgeries, one to place the balloon and a second to remove the balloon before delivery.

Device: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

Expectant Management Arm

NO INTERVENTION

Participants choose to undergo the expectant management, or routine care, of carrying a baby with Congenital Diaphragmatic Hernia (CDH). Participants will undergo a comprehensive fetal evaluation at Michigan Medicine's Fetal Diagnosis and Treatment Center (FDTC) to confirm the diagnosis and severity of the CDH. Eligibility will be based on the results of the clinical assessment.

Interventions

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) DEVICE

This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.

FETO surgery Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
• Pregnant women, age 18 years and older
• Singleton pregnancy
• Normal fetal karyotype, Chromosomal Microarray (CMA) with non-pathologic variants, Whole Exome Sequencing (WES) or Whole Genome Sequencing (WGS). Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \>26 weeks.
• Gestational age at enrollment prior to 29w6d
• Fetal CDH with intrathoracic liver herniation with either:
• Isolated left CDH with Observed/Expected (o/e) Lung to Head Ratio (LHR) \<30% at enrollment (18w0d-29w5d)
• Isolated right CDH with o/e LHR \<45% at enrollment (18w0d-29w5d)
• Cervical length by transvaginal ultrasound \>20 mm within 24hours of FETO procedure
• Meets psychosocial criteria
• Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
• Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with participant for the duration of the pregnancy near Von Voigtlander Women's Hospital
• Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work (work from home approved by Principal Investigator is okay)
• Provision of signed and dated informed consent form

You may not qualify if:

• Patient \<18 years of age
• Multi-fetal pregnancy
• History of natural rubber latex allergy
• Preterm labor, short cervix (\<20mm within 24 hours of FETO balloon insertion procedure), or uterine anomaly strongly predisposing to preterm labor, placenta previa
• History of incompetent cervix with or without cerclage
• Psychosocial ineligibility
• Inability to reside within 30 minutes of Von Voigtlander Women's Hospital or inability to maintain follow up appointments
• Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude participant as a potential candidate (per protocol).
• Bilateral CDH, isolated Left Congenital Diaphragmatic Hernia (LCDH) with o/e LHR \> 30% (measured at 180 to 295 weeks), isolated Right Congenital Diaphragmatic Hernia (RCDH) with o/e LHR \>45% (measured at 180 to 295 weeks) as determined by ultrasound
• No liver herniation into the thoracic cavity.
• Additional fetal anomaly or genetic/chromosomal abnormalities 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.
• Maternal contraindications to elective fetoscopic surgery or severe maternal medical condition in pregnancy
• Placental abnormalities (previa, abruption, accreta) known at time of enrollment and/or surgery
• Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• Maternal Human Immunodeficiency Virus (HIV), Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment

Sponsors & Collaborators

• Dr Erin Perrone: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin Perrone, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Carter

CONTACT

734-615-3883; irenestc@med.umich.edu

Erin Perrone, MD

CONTACT

734-936-8464; eperrone@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Model Details: Participants will choose between 2 courses of care. One group is the FETO surgery Intervention Arm and the other group is the Expectant Management Arm. It is expected that there will be 20 participants in each group.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)