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NCT04583644 · ClinicalTrials.gov registry record · NA
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
A NA study of Congenital Diaphragmatic Hernia, sponsored by Hanmin Lee.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04583644: Recruiting NA study of Congenital Diaphragmatic Hernia, sponsored by Hanmin Lee.
NCT04583644 is a NA study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by Hanmin Lee. The registered enrollment target is 10 participants, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04583644, a NA study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by Hanmin Lee.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The rationale for fetal therapy in severe CDH is to promote adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. The investigator's goal with this pilot study is to study the feasibility of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with left CDH (LHR O/E \< 25%).
Primary Outcome
Number of effective placements of balloon to occlude trachea via fetoscopy by performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) in fetuses with severe left congenital diaphragmatic hernia (CDH), as defined by lung to head ratio (LHR) Observed/Expected \< 25%
Conditions Studied
Interventions
- DEVICE Fetoscopic Endoluminal Tracheal Occlusion Surgery
Study Locations (1)
California
- University of California San Francisco Fetal Treatment Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2028-04 |
| Phase | NA |
What NCT04583644 shows while recruiting
NCT04583644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which Fetoscopic Endoluminal Tracheal Occlusion Surgery is the first listed.
NCT04583644 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04583644 about?
NCT04583644 is a clinical study titled "Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)". Despite advances in prenatal diagnosis and postnatal therapies, including ECMO (Extracorporeal Membrane Oxygenation), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. The ration...
What is the current status of trial NCT04583644?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2020-10-02. Estimated completion is 2028-04.
What conditions does trial NCT04583644 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.
What interventions are being tested in trial NCT04583644?
The interventions under investigation include: Fetoscopic Endoluminal Tracheal Occlusion Surgery (DEVICE).
Who is sponsoring clinical trial NCT04583644?
This trial is sponsored by Hanmin Lee, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04583644 being conducted?
This trial has 1 study location across California. 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 NCT04583644's enrollment target sits among peer trials
10 18th of 22 the lowest 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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Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
Safety and Efficacy of FETO in CDH: A Phase III Trial
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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