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Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Primary Purpose

Hernia, DIaphragmatic, Congenital

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FETO therapy
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Hernia, DIaphragmatic, Congenital

Eligibility Criteria

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

Inclusion Criteria: A subject is defined as a female (18 years or older) who is pregnant. The pregnancy must be a singleton pregnancy. The CDH must be left-sided. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements). No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days. Cervix length longer than 20 mm at pre-balloon placement evaluation. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis. Written consent must be obtained. Must meet psychosocial criteria including appropriate family/friend support during stay with balloon in place (cannot stay without additional helper), no current illicit drug use, no over-the-counter drug abuse, and no ineffectively treated DSM-IV diagnoses. Exclusion Criteria: Twin or higher order gestation Not able to consent Right-sided or bilateral CDH Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome Maternal isoimmunization or neonatal alloimmune thrombocytopenia Balloon not able to be placed prior to 30 weeks gestation CDH O/E LHR 25% or greater Maternal factors precluding safe fetal surgery (maternal cardiac findings not safe for anesthesia, maternal morbid obesity precluding safe usage of the equipment required for entry into the uterus, spontaneous preterm delivery prior to 36 weeks) Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risks of fetal transmission during procedures Short cervix (20 mm or less) History of incompetent cervix or uterine anomaly predisposing to preterm labor Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery History of natural rubber latex allergy No safe or feasible fetoscopic approach to balloon placement Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota

Sites / Locations

  • Midwest Fetal Care CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FETO therapy

Arm Description

FETO therapy

Outcomes

Primary Outcome Measures

Successful placement of Balt Goldbal2 balloon
Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure.
Successful removal of Balt Goldbal2 balloon
Removal of the balloon

Secondary Outcome Measures

Change in fetal lung growth
Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal.
Gestational age at delivery
Gestational age at delivery will be recorded.
Infant survival
Infant survival will be recorded from delivery to NICU discharge, and at 6, 12, and 24 months of age
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Use of ECMO will be collected from medical chart review.
Number of infants requiring tracheostomy while in the NICU
Tracheostomy information will be collected from medical chart review.
Number of infants requiring home oxegen support upon discharge from the NICU
Oxegen support will be collected from medical chart review.
Time to pulmonary hypertension resolution
pulmonary hypertension will be collected from medical chart review.

Full Information

First Posted
February 16, 2023
Last Updated
March 14, 2023
Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
Allina Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05771688
Brief Title
Fetoscopic Endoluminal Tracheal Occlusion
Acronym
FETO
Official Title
Fetoscopic Endoluminal Tracheal Occlusion for Severe Left-sided Congenital Diaphragmatic Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
February 2028 (Anticipated)
Study Completion Date
September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
Allina Health System

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 study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's MN. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.
Detailed Description
This is a single site pilot trial to assess the feasibility and safety of treating the most severe group of fetuses with left CDH with Fetal Endoluminal Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Midwest Fetal Care Center (MWFCC), a collaboration between Allina Health and Children's MN. Congenital Diaphragmatic Hernia (CDH) is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up in the lungs and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life. The rationale for fetal therapy in severe CDH is to improve fetal lung growth and therefore neonatal survival. The study will enroll pregnant women that meet study criteria, and their baby. The mother-fetus participant will undergo one procedure for placement of FETO before gestational age 29 weeks 6 days; and a second procedure for removal of the FETO device. The timing for removal of FETO is no later than 35 weeks and 6 days. After delivery, routine care of the baby with CDH will occur within the Children's MN NICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, DIaphragmatic, Congenital

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
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FETO therapy
Arm Type
Experimental
Arm Description
FETO therapy
Intervention Type
Device
Intervention Name(s)
FETO therapy
Other Intervention Name(s)
Fetoscopic Endoluminal Tracheal Occlusion, GOLDBALLOON, BALTACCI
Intervention Description
placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days
Primary Outcome Measure Information:
Title
Successful placement of Balt Goldbal2 balloon
Description
Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure.
Time Frame
Prior to 29 weelks 6 days GA
Title
Successful removal of Balt Goldbal2 balloon
Description
Removal of the balloon
Time Frame
Prior to 35 weeks 6 days GA
Secondary Outcome Measure Information:
Title
Change in fetal lung growth
Description
Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal.
Time Frame
Immediatly after intervention (device removal)
Title
Gestational age at delivery
Description
Gestational age at delivery will be recorded.
Time Frame
Measured at time of delivery
Title
Infant survival
Description
Infant survival will be recorded from delivery to NICU discharge, and at 6, 12, and 24 months of age
Time Frame
Birth - 24 months
Title
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
Description
Use of ECMO will be collected from medical chart review.
Time Frame
Birth to 6 months
Title
Number of infants requiring tracheostomy while in the NICU
Description
Tracheostomy information will be collected from medical chart review.
Time Frame
up to 2 years of age
Title
Number of infants requiring home oxegen support upon discharge from the NICU
Description
Oxegen support will be collected from medical chart review.
Time Frame
up to 2 years of age
Title
Time to pulmonary hypertension resolution
Description
pulmonary hypertension will be collected from medical chart review.
Time Frame
up to 2 years of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A subject is defined as a female (18 years or older) who is pregnant. The pregnancy must be a singleton pregnancy. The CDH must be left-sided. The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements). No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype. Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects. Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days. Cervix length longer than 20 mm at pre-balloon placement evaluation. Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis. Written consent must be obtained. Must meet psychosocial criteria including appropriate family/friend support during stay with balloon in place (cannot stay without additional helper), no current illicit drug use, no over-the-counter drug abuse, and no ineffectively treated DSM-IV diagnoses. Exclusion Criteria: Twin or higher order gestation Not able to consent Right-sided or bilateral CDH Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome Maternal isoimmunization or neonatal alloimmune thrombocytopenia Balloon not able to be placed prior to 30 weeks gestation CDH O/E LHR 25% or greater Maternal factors precluding safe fetal surgery (maternal cardiac findings not safe for anesthesia, maternal morbid obesity precluding safe usage of the equipment required for entry into the uterus, spontaneous preterm delivery prior to 36 weeks) Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risks of fetal transmission during procedures Short cervix (20 mm or less) History of incompetent cervix or uterine anomaly predisposing to preterm labor Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery History of natural rubber latex allergy No safe or feasible fetoscopic approach to balloon placement Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James E Fisher, MD
Phone
612.863.9924
Email
jfisher@pediatricsurgical.com
Facility Information:
Facility Name
Midwest Fetal Care Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James E Fisher, MD
Phone
612-863-9924
Email
jfisher@pediatricsurgical.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fetoscopic Endoluminal Tracheal Occlusion

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