Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

NCT ID: NCT02530073

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2030-08-31

Brief Summary

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

Detailed Description

Prenatal tracheal occlusion (TO) obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.

The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio < 25%(O/E LHR < 25%).

Conditions

Congenital Diaphragmatic Hernias

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

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

Group Type: EXPERIMENTAL

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Intervention Type: 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).

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

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).

Intervention Type: DEVICE

Other Intervention Names

BALT GOLDBAL2 Tracheal Balloon Catheter system

Eligibility Criteria

Inclusion Criteria

• 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%

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Connecticut Children's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Timothy Crombleholme

Director of Fetal Care Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Crombleholme, MD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katie E Boyle, MPH

Role: CONTACT

Kboyle01@connecticutchildrens.org

860-837-6547

Facility Contacts

Katie E Boyle, MPH

Role: primary

Kboyle01@connecticutchildrens.org

860-837-6547

Other Identifiers

22-133

Identifier Type: -

Identifier Source: org_study_id

NCT06064188

Identifier Type: -

Identifier Source: nct_alias