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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 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.
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%).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04583644
The ClinicalTrials.gov registry entry for NCT04583644 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (95% lower). The listed sponsor is Hanmin Lee, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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