Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) (FETO)
Primary Purpose
Congenital Diaphragmatic Hernias
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Diaphragmatic Hernias focused on measuring congenital diaphragmatic hernia, FETO, tracheal occlusion
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
Sites / Locations
- Medical City Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Arm Description
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
Outcomes
Primary Outcome Measures
Percent of neonatal survivors at time of discharge
Secondary Outcome Measures
Prenatal increase in lung volume
Lung volume after FETO procedure
Number of days of Postnatal mechanical ventilator support
mechanical ventilator support will be monitored and recorded in days of use
Full Information
NCT ID
NCT02530073
First Posted
July 31, 2015
Last Updated
February 18, 2020
Sponsor
Medical City Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02530073
Brief Title
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Acronym
FETO
Official Title
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical City Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernias
Keywords
congenital diaphragmatic hernia, FETO, tracheal occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Arm Type
Experimental
Arm Description
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
Intervention Type
Device
Intervention Name(s)
Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Other Intervention Name(s)
BALT GOLDBAL2 Tracheal Balloon Catheter system
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percent of neonatal survivors at time of discharge
Time Frame
Discharge from the hospital, an expected average of 12 weeks.
Secondary Outcome Measure Information:
Title
Prenatal increase in lung volume
Description
Lung volume after FETO procedure
Time Frame
2 weeks (prenatally)
Title
Number of days of Postnatal mechanical ventilator support
Description
mechanical ventilator support will be monitored and recorded in days of use
Time Frame
First 28 days of postnatal life
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madeline C Crank, NP
Phone
972-566-5600
Email
mcrank@fetalcarecenter.md
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Crombleholme, MD
Organizational Affiliation
Medical City Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical City Children's Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeline C Crank, NP
Phone
972-566-5600
Email
mcrank@fetalcarecenter.md
12. IPD Sharing Statement
Learn more about this trial
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO)
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