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NCT06884423 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of FETO in CDH: A Phase III Trial
A NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, sponsored by Holly L Hedrick, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT06884423: Recruiting NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, sponsored by Holly L Hedrick, MD.
NCT06884423 is a NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia that is actively recruiting participants, run by Holly L Hedrick, MD. The registered enrollment target is 80 participants, below the 193-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (59% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06884423, a NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, is actively recruiting participants, sponsored by Holly L Hedrick, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study Summary
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
Primary Outcome
Evalutation of successful placement and removal of the fetoscopic endoluminal tracheal occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with observed/expected lung to head ratio (O/E LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%.
Conditions Studied
Interventions
- DEVICE FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
Study Locations (2)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2032-04 |
| Phase | NA |
What NCT06884423 shows while recruiting
NCT06884423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 193-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter is the first listed.
NCT06884423 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06884423 about?
NCT06884423 is a clinical study titled "Safety and Efficacy of FETO in CDH: A Phase III Trial". Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs f...
What is the current status of trial NCT06884423?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-04-07. Estimated completion is 2032-04.
What conditions does trial NCT06884423 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia.
What interventions are being tested in trial NCT06884423?
The interventions under investigation include: FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter (DEVICE).
Who is sponsoring clinical trial NCT06884423?
This trial is sponsored by Holly L Hedrick, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06884423 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Diaphragmatic Hernia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06884423's enrollment target sits among peer trials
80 3rd of 22 higher than 17 of 22 other Congenital Diaphragmatic Hernia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Diaphragmatic Hernia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
Trial of FETO for Severe Congenital Diaphragmatic Hernia
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
RECRUITING · NA
-
High Frequency Oscillatory Ventilation Versus High Frequency Jet Ventilation for Congenital Diaphragmatic Hernia
RECRUITING · NA
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