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Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Sponsor
Medical City Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02530073
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
89
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent of neonatal survivors at time of discharge [Discharge from the hospital, an expected average of 12 weeks.]

    Secondary Outcome Measures

    1. Prenatal increase in lung volume [2 weeks (prenatally)]

      Lung volume after FETO procedure

    2. Number of days of Postnatal mechanical ventilator support [First 28 days of postnatal life]

      mechanical ventilator support will be monitored and recorded in days of use

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical City Children's Hospital Dallas Texas United States 75230

    Sponsors and Collaborators

    • Medical City Children's Hospital

    Investigators

    • Principal Investigator: Timothy Crombleholme, MD, Medical City Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical City Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02530073
    Other Study ID Numbers:
    • 15-0874
    First Posted:
    Aug 20, 2015
    Last Update Posted:
    Feb 19, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Medical City Children's Hospital
    congenital diaphragmatic hernia
    FETO
    tracheal occlusion
    Additional relevant MeSH terms:
    Hernias, Diaphragmatic, Congenital
    Hernia
    Hernia, Diaphragmatic

    Study Results

    No Results Posted as of Feb 19, 2020