Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

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

Study Overview

• Status: Recruiting
• Conditions: Congenital Diaphragmatic Hernias
• Intervention / Treatment: Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)

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%).

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy Crombleholme, MD; Phone Number: 860-545-9830; Email: tcrombleholme@connecticutchildrens.org
• Study Contact Backup: Name: James Santanelli, MS, MPH; Phone Number: 860-837-5873; Email: jsantanelli@connecticutchildrens.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Connecticut Children's Medical Center
      • Contact: Timothy Crombleholme, MD; Phone Number: 860-545-9830; Email: tcrombleholme@connecticutchildrens.org
      • Contact: James Santanelli, MS, MPH; Phone Number: 8608375873; Email: jsantanelli@connecticutchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant women age 18 years and older, who are able to consent
• Singleton pregnancy

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fetoscopic Endoluminal Tracheal Occlusion (FETO); An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)	Device: 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).; Other Names: BALT GOLDBAL2 Tracheal Balloon Catheter system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of neonatal survivors at time of discharge	Percent of neonatal survivors at time of discharge	Discharge from the hospital, an expected average of 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prenatal increase in lung volume	Lung volume after FETO procedure	2 weeks (prenatally)
Number of days of Postnatal mechanical ventilator support	mechanical ventilator support will be monitored and recorded in days of use	First 28 days of postnatal life

Collaborators and Investigators

• Sponsor: Timothy Crombleholme
• Investigators: Principal Investigator: Timothy Crombleholme, MD, Connecticut Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 22-133 FETO

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