Fetoscopic Endoluminal Tracheal Occlusion

NCT05771688 | Recruiting DMC FDA Device

• 1 other identifier: 1397678; 2021-055
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 Minnesota. 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.

Conditions

Hernia, DIaphragmatic, Congenital

Outcome Measures

Primary Outcomes (2)

• 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.

  Prior to 29 weeks 6 days Gestational Age (GA)

• Successful removal of Balt Goldbal2 balloon

  Removal of the balloon

  Prior to 35 weeks 6 days GA

Secondary Outcomes (7)

• Change in fetal lung growth

  Immediately after intervention (device removal)

• Gestational age at delivery

  Measured at time of delivery

• Infant survival

  Birth - 24 months

• Number of infants requiring extra corporeal membrane oxygenation (ECMO) support

  Birth to 6 months

• Number of infants requiring tracheostomy while in the NICU

  up to 2 years of age

Study Arms (1)

FETO therapy

EXPERIMENTAL

FETO therapy

Device: FETO therapy

Interventions

FETO therapy DEVICE

placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days

Also known as: Fetoscopic Endoluminal Tracheal Occlusion, GOLDBALLOON, BALTACCI

FETO therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead
• Allina Health System: collaborator

Study Sites (1)

Midwest Fetal Care Center

Minneapolis, Minnesota, 55404, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Diaphragmatic

Condition Hierarchy (Ancestors)

Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

James E Fisher, MD

CONTACT

612.863.9924; jfisher@pediatricsurgical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 16, 2023
• Study Start: February 22, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)