Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia (FETO)
Primary Purpose
Congenital Diaphragmatic Hernia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FETO therapy
Sponsored by
About this trial
This is an interventional device feasibility trial for Congenital Diaphragmatic Hernia focused on measuring Fetoscopic Endoluminal Tracheal Occlusion, Congenital Diaphragmatic Hernia
Eligibility Criteria
Inclusion Criteria:
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- Isolated Left CDH with liver up
- LHR < 25% - Gestation age at enrollment prior to 29 wks plus 6 days; O/E LHR 25- <30% - gestation age at time of enrollment prior to 31 wks plus 6 days
- SEVERE pulmonary hypoplasia with US O/E LHR < 25% (measured at 18 weeks plus 0 days to 29 weeks plus 5 days) at the time of surgery; O/E LHR 25- <30% (measured at 30 weeks plus 0 days - 31 weeks plus 6 days) at time of surgery.
- Gestational age at FETO procedure with O/E LHR < 25% at 27 weeks plus 0 days to 29 weeks plus 6 days; O/E LHR 25- <30% at FETO procedure at 30 weeks plus 0 days - 31 weeks plus 6 days as determined by clinical information (LMP) and evaluation of first ultrasound.
- Patient meets psychosocial criteria
- Informed consent
Exclusion Criteria:
- Patient < 18 years of age
- Multi-fetal pregnancy
- History of natural 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:
- Inability to reside within 30 minutes of The Fetal Center at Children's Memorial Hermann Hospital. and inability to comply with the travel for the follow-up requirements of the trial
- Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at The Fetal Center at Children's Memorial Hermann Hospital.
- Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥25% (measured at 18 weeks 0 days to 29 weeks 5 days) as determined by ultrasound[1]
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accrete) known at time of enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- There is no safe or technically feasible fetoscopic approach to balloon placement
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FETO therapy
Arm Description
Intervention name: FETO therapy
Outcomes
Primary Outcome Measures
Successful placement of Balt Goldbal2 balloon
Successful removal of Balt Goldbal2 balloon
Gestational age at delivery
Secondary Outcome Measures
Lung volume
Lung head ratio
Survival at 30 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02596802
Brief Title
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia
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
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anthony Johnson
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia
Keywords
Fetoscopic Endoluminal Tracheal Occlusion, Congenital Diaphragmatic Hernia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FETO therapy
Arm Type
Experimental
Arm Description
Intervention name: FETO therapy
Intervention Type
Device
Intervention Name(s)
FETO therapy
Intervention Description
Fetoscopic surgery at 27 to 31 weeks and 6 days gestation.
Primary Outcome Measure Information:
Title
Successful placement of Balt Goldbal2 balloon
Time Frame
7 weeks after placement
Title
Successful removal of Balt Goldbal2 balloon
Time Frame
within 5 weeks prior to delivery
Title
Gestational age at delivery
Time Frame
at delivery
Secondary Outcome Measure Information:
Title
Lung volume
Time Frame
7 weeks after placement of balloon
Title
Lung head ratio
Time Frame
7 weeks after placement of balloon
Title
Survival at 30 days
Time Frame
30 days post delivery
Other Pre-specified Outcome Measures:
Title
Maternal complications
Description
Maternal complications include preterm labor, premature preterm rupture of membranes, oligohydramnios, polyhydramnios, and chorioamnionitis.
Time Frame
After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women age 18 years and older
Singleton pregnancy
Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
Isolated Left CDH with liver up
LHR < 25% - Gestation age at enrollment prior to 29 wks plus 6 days; O/E LHR 25- <30% - gestation age at time of enrollment prior to 31 wks plus 6 days
SEVERE pulmonary hypoplasia with US O/E LHR < 25% (measured at 18 weeks plus 0 days to 29 weeks plus 5 days) at the time of surgery; O/E LHR 25- <30% (measured at 30 weeks plus 0 days - 31 weeks plus 6 days) at time of surgery.
Gestational age at FETO procedure with O/E LHR < 25% at 27 weeks plus 0 days to 29 weeks plus 6 days; O/E LHR 25- <30% at FETO procedure at 30 weeks plus 0 days - 31 weeks plus 6 days as determined by clinical information (LMP) and evaluation of first ultrasound.
Patient meets psychosocial criteria
Informed consent
Exclusion Criteria:
Patient < 18 years of age
Multi-fetal pregnancy
History of natural 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:
Inability to reside within 30 minutes of The Fetal Center at Children's Memorial Hermann Hospital. and inability to comply with the travel for the follow-up requirements of the trial
Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at The Fetal Center at Children's Memorial Hermann Hospital.
Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥25% (measured at 18 weeks 0 days to 29 weeks 5 days) as determined by ultrasound[1]
Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
History of incompetent cervix with or without cerclage
Placental abnormalities (previa, abruption, accrete) known at time of enrollment
Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
There is no safe or technically feasible fetoscopic approach to balloon placement
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Johnson, DO
Phone
832 325-7288
Email
Anthony.Johnson@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Johnson, DO
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Johnson, DO
Phone
832-325-7288
Email
Anthony.Johnson@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Percy Pacora Portella, MD, MPH
Phone
713-500-6421
Email
Percy.N.PacoraPortella@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia
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