Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

NCT02530073 | Recruiting DMC FDA Device

• 1 other identifier: 22-133
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Conditions

Congenital Diaphragmatic Hernias

Keywords

congenital diaphragmatic hernia; FETO; tracheal occlusion

Outcome Measures

Primary Outcomes (1)

• Percent of neonatal survivors at time of discharge

  Feasibility, safety, and survival rates of the FETO procedure

  Discharge from the hospital, an expected average of 12 weeks.

Secondary Outcomes (4)

• Prenatal increase in lung volume

  2 weeks (prenatally)

• Number of days of Postnatal mechanical ventilator support

  First 28 days of postnatal life

• Changes in RNA content of tracheal and amniotic fluid

  At time of balloon placement and removal

• Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid

  At time of balloon placement and removal

Study Arms (1)

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

EXPERIMENTAL

An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)

Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO) DEVICE

This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio \<25% (O/E LHR).

Also known as: BALT GOLDBAL2 Tracheal Balloon Catheter system

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Eligibility Criteria

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

You may qualify if:

• Pregnant women age 18 years and older, who are able to consent
• Singleton pregnancy
• Fetal
• Normal Karyotype
• Fetal Diagnosis of Isolated Left CDH with liver up
• Gestation at enrollment prior to 29 wks plus 6 days
• SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR \< 25%

You may not qualify if:

• Pregnant women \<18 years of age.
• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• Technical limitations precluding fetoscopic surgery
• 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
• Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
• Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

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

• Timothy Crombleholme, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie E Boyle, MPH

CONTACT

860-837-6547; Kboyle01@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Fetal Care Center

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 20, 2015
• Study Start: September 1, 2015
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)