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Fetal Endoscopic Tracheal Occlusion for CDH (CDH) (FETO)

Primary Purpose

Congenital Diaphragmatic Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Diaphragmatic Hernia focused on measuring Congenital Diaphragmatic Hernia, Fetal endoscopic tracheal occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study
  3. Pregnant women, age 18 years and older
  4. Singleton pregnancy
  5. No pathogenic variants on microarray or pathologic findings on karyotype
  6. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
  7. Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25% with liver up
  8. Gestational age at FETO procedure: if o/e LHR <25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days

  9. Meets psychosocial criteria

    • Willing to reside within 30 minutes of UC Davis Medical Center and ability to maintain follow up appointments
    • Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near the UC Davis Medical Center.
    • Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work

Exclusion Criteria:

  1. Adults unable to consent
  2. Prisoners
  3. Multi-fetal pregnancy
  4. History of latex allergy
  5. History of preterm labor or incompetent cervix (requiring cerclage), short cervix (<20mm), or uterine anomaly predisposing to preterm labor

  6. Psychosocial ineligibility

    • Inability to reside within 30 minutes of UC Davis Medical Center or inability to maintain follow up appointments
    • Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
  7. Bilateral CDH, unilateral CDH with o/e LHR > 25% or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
  8. Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
  9. Maternal contraindications to elective fetoscopic surgery
  10. Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
  11. Maternal isoimmunization or neonatal alloimmune thrombocytopenia
  12. Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
  13. No safe or feasible fetoscopic approach to balloon placement

Sites / Locations

  • UC Davis Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FETO with GOLDBAL2

Arm Description

A balloon will be placed in the airway of the fetus during the FETO procedure.

Outcomes

Primary Outcome Measures

Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Number of successful retrievals of the GOLDBAL2
This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.

Secondary Outcome Measures

Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)
Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.
Change in fetal lung growth
Fetal ultrasounds will be done weekly while the balloon is in place. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR immediately prior to balloon removal.
Gestational age at delivery
Survival of infant to hospital discharge or 180 days after hospitalized
This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point.
Number of maternal complications
Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection.

Full Information

First Posted
June 8, 2022
Last Updated
June 15, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05421676
Brief Title
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
Acronym
FETO
Official Title
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis

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
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at UC Davis Medical Center. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at UC Davis Medical Center. This study requires that study participants live within 30 minutes of the UC Davis Medical Center in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia
Keywords
Congenital Diaphragmatic Hernia, Fetal endoscopic 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
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FETO with GOLDBAL2
Arm Type
Experimental
Arm Description
A balloon will be placed in the airway of the fetus during the FETO procedure.
Intervention Type
Device
Intervention Name(s)
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Intervention Description
This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
Primary Outcome Measure Information:
Title
Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation.
Description
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Time Frame
27 weeks 0 days to 29 weeks 6 days
Title
Number of successful retrievals of the GOLDBAL2
Description
This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.
Time Frame
Removal prior to delivery approximately 34 weeks of gestation
Secondary Outcome Measure Information:
Title
Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)
Description
Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.
Time Frame
baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval
Title
Change in fetal lung growth
Description
Fetal ultrasounds will be done weekly while the balloon is in place. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR immediately prior to balloon removal.
Time Frame
baseline (before balloon placement), immediately prior to balloon retrieval
Title
Gestational age at delivery
Time Frame
At the time of delivery (up to approximately 34 weeks)
Title
Survival of infant to hospital discharge or 180 days after hospitalized
Description
This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point.
Time Frame
Discharge from hospital or up to 180 days in the hospital
Title
Number of maternal complications
Description
Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection.
Time Frame
up to 4-6 weeks postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability (meets psychosocial criteria below) for the duration of the study Pregnant women, age 18 years and older Singleton pregnancy No pathogenic variants on microarray or pathologic findings on karyotype Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as o/e LHR <25% with liver up Gestational age at FETO procedure: if o/e LHR <25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days Meets psychosocial criteria Willing to reside within 30 minutes of UC Davis Medical Center and ability to maintain follow up appointments Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near the UC Davis Medical Center. Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work Exclusion Criteria: Adults unable to consent Prisoners Multi-fetal pregnancy History of latex allergy History of preterm labor or incompetent cervix (requiring cerclage), short cervix (<20mm), or uterine anomaly predisposing to preterm labor Psychosocial ineligibility Inability to reside within 30 minutes of UC Davis Medical Center or inability to maintain follow up appointments Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate. Bilateral CDH, unilateral CDH with o/e LHR > 25% or unilateral CDH with o/e LHR <25% but liver completely down in abdomen Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome Maternal contraindications to elective fetoscopic surgery Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery Maternal isoimmunization or neonatal alloimmune thrombocytopenia Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure No safe or feasible fetoscopic approach to balloon placement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Powne, MSN, RN
Phone
916-717-4690
Email
fctc@ucdavis.edu
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Powne, MSN, RN
Phone
916-717-4690
Email
fctc@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Shinjiro Hirose, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

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