Loading clinical trials...

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)

NCT02596802•Anthony Johnson

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

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
•O/E LHR \< 30% - Gestation age at time of enrollment prior to 29 wks plus 5 days as determined by clinical information (LMP, 1st or 2nd trimester ultrasound) and evaluation of first ultrasound (measured at 270 to 296 weeks) at the time of surgery
•Gestational age at FETO procedure with O/E LHR \< 30% at 27 weeks 0 days to 29 weeks 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
+5 more criteria

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

December 1, 2015

Primary Completion Date

December 20, 2024

Completion Date

January 20, 2026

Last Updated

January 24, 2025

Enrollment

ACTUAL participants

Conditions

Congenital Diaphragmatic Hernia

Interventions

FETO therapy

DEVICE

An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels

NCT06731855

GastroschisisCongenital Diaphragmatic Hernia+4 more

View study

RECRUITINGNA

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

NCT07166172

Congenital Diaphragmatic HerniaCongenital Abnormalities+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia

Inclusion Criteria

Exclusion Criteria

An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

Fetoscopic Endoluminal Tracheal Occlusion

Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia

Maternal-fetal Immune Responses to Fetal Surgery

Genetic Analysis of Congenital Diaphragmatic Disorders