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NCT05354505 · ClinicalTrials.gov registry record · NA
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
A NA study of Diaphragmatic Hernia, sponsored by Vincent Duron.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05354505: Recruiting NA study of Diaphragmatic Hernia, sponsored by Vincent Duron.
NCT05354505 is a NA study of Diaphragmatic Hernia that is actively recruiting participants, run by Vincent Duron. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05354505, a NA study of Diaphragmatic Hernia, is actively recruiting participants, sponsored by Vincent Duron.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).
Primary Outcome
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Conditions Studied
Interventions
- DEVICE Placement of the GOLDBAL2 balloon
Study Locations (1)
New York
- Columbia University Irving Medical Center/NewYork-Presbyterian - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-01 |
| Est. Completion | 2028-06 |
| Phase | NA |
What NCT05354505 shows while recruiting
NCT05354505 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which Placement of the GOLDBAL2 balloon is the first listed.
NCT05354505 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05354505 about?
NCT05354505 is a clinical study titled "Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)". This is a single site, single arm, non-randomized, pilot trial to assess the feasibility and safety of treating severe congenital diaphragmatic hernia (CDH) with Fetal Endoscopic Tracheal Occlusion (FETO) at Columbia University Irving Medical Center (CUIMC)/ NewYork-Presbyterian Hospital (NYP).
What is the current status of trial NCT05354505?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2026-01. Estimated completion is 2028-06.
What conditions does trial NCT05354505 study?
This clinical trial studies the following conditions: Diaphragmatic Hernia.
What interventions are being tested in trial NCT05354505?
The interventions under investigation include: Placement of the GOLDBAL2 balloon (DEVICE).
Who is sponsoring clinical trial NCT05354505?
This trial is sponsored by Vincent Duron, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05354505 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05354505's enrollment target sits among peer trials
10 1928th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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 for Congenital Diaphragmatic Hernia