deltatrials
Recruiting INTERVENTIONAL NCT07166172

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

North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

Sponsor: Johns Hopkins University

Updated 2 times since 2025 Last updated: Apr 20, 2026 Started: Jun 23, 2025 Primary completion: Dec 1, 2029 Completion: Dec 1, 2031
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Congenital Abnormalities and Congenital Diaphragmatic Hernia and is currently actively recruiting participants. Johns Hopkins University leads this study, which shows 2 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR ≤ 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27 weeks + 0 days to 29weeks + 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH \< 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR ≤ 45% that undergo FETO procedure performed at 27 weeks + 0 days to 29 weeks + 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR ≤ 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure...

The purpose of this study is to evaluate successful placement and removal of Fetoscopic Endoluminal Tracheal Occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with Observed/Expected (O/E) Lung to Head Circumference Ratio (LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR ≤ 45%,to compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27 weeks + 0 days to 29weeks + 6 days of gestation to those with intrathoracic liver herniation, isolated LCDH and o/e LRH \< 30% that undergo expectant management, to compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCHD with o/e LHR ≤ 45% that undergo FETO procedure performed at 27 weeks + 0 days to 29 weeks + 6 days gestation to those with intrathoracic liver herniation, isolated RCHD and o/e LHR ≤ 45% that elect to proceed with expectant management, to evaluate the frequency of maternal and fetal complications associated with FETO procedure, to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated LCDH survivors with o/e LHR \<30% when compared to isolated LCDH with o/e LRH \<30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation and to evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities in isolated RCDH survivors with o/e LHR ≤ 45% when compared to isolated RCHD with LHR ≤ 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.

Status Flow

~Oct 2025 – ~Apr 2026 · 7 months · monthly snapshotRecruitingApr 28, 2026 – present · 2 months · daily APIRecruiting

Change History

2 versions recorded
  1. Apr 28, 2026 — Present [daily]

    Recruiting

    Phase: NANone

  2. Oct 2025 — Apr 2026 [monthly]

    Recruiting NA

    First recorded

Jun 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.

Contact Information

Sponsor contact:
  • Johns Hopkins University
  • KARL STORZ Endoscopy-America, Inc.
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations