Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

NCT02986087 | Recruiting DMC FDA Device

• 1 other identifier: 2015-6413
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Conditions

Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia; Pulmonary; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change lung growth on prenatal imaging

  Change in o/eLHR and other prenatal imaging tests

  prenatal period up to 40 weeks gestation

Secondary Outcomes (4)

• Change survival in the severe congenital diaphragmatic hernia subgroup

  6 months

• Change need for ECMO therapy

  6 months

• Change pulmonary hypertension

  6 months

• Change neonatal morbidity

  1 year

Study Arms (1)

Fetal Tracheal Occlusion

EXPERIMENTAL

Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.

Device: Fetal Tracheal Occlusion

Interventions

Fetal Tracheal Occlusion DEVICE

Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of \<25%, LHR \<1, o/e LHR\<30% (moderate), singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days, no maternal disease, maternal age \> 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.

Also known as: FETO, Fetal Endoluminal Tracheal Occlusion

Fetal Tracheal Occlusion

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Isolated CDH with liver up
• Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery
• Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
• Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery
• Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
• Maternal age greater than or equal to 18 years
• Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
• Normal karyotype or FISH
• Normal fetal echocardiogram
• Singleton pregnancy
• Willing to remain in the greater Cincinnati area for remainder of pregnancy
• Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
• Family meets psychosocial criteria

You may not qualify if:

• Patient \< 18 years old
• Multi-fetal pregnancy
• Rubber latex allergy
• Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• Bilateral CDH, isolated left sided CDH with an O/E \> 30%
• Additional fetal anomaly by ultrasound, MRI, or echocardiogram
• Chromosomal abnormalities
• Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
• Incompetent cervix with or without a cerclage
• Placental abnormalities known at time of enrollment
• Maternal HIV, Hepatits B, Hepatitis C
• Maternal uterine anomaly
• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center (CCHMC)

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kurt Schibler, MD

  CCHMC Oversight Data Safety Monitoring Committee

  STUDY CHAIR

Central Study Contacts

Foong-Yen Lim, MD

CONTACT

(513) 636-6259; Foong-Yen.Lim@cchmc.org

Jose Peiro, MD, PhD

CONTACT

(513) 803-4563; Jose.Peiro@cchmc.org

Study Design

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

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)