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NCT05450653 · ClinicalTrials.gov registry record · NA
Trial of FETO for Severe Congenital Diaphragmatic Hernia
A NA study of Congenital Diaphragmatic Hernia, sponsored by Aimen F. Shaaban, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05450653: Recruiting NA study of Congenital Diaphragmatic Hernia, sponsored by Aimen F. Shaaban, MD.
NCT05450653 is a NA study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by Aimen F. Shaaban, MD. 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
NCT05450653, a NA study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by Aimen F. Shaaban, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.
Primary Outcome
Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure.
Conditions Studied
Interventions
- DEVICE FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-09-18 |
| Est. Completion | 2031-11 |
| Phase | NA |
What NCT05450653 shows while recruiting
NCT05450653 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 FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) is the first listed.
NCT05450653 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05450653 about?
NCT05450653 is a clinical study titled "Trial of FETO for Severe Congenital Diaphragmatic Hernia". This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to in...
What is the current status of trial NCT05450653?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2022-09-18. Estimated completion is 2031-11.
What conditions does trial NCT05450653 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.
What interventions are being tested in trial NCT05450653?
The interventions under investigation include: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) (DEVICE).
Who is sponsoring clinical trial NCT05450653?
This trial is sponsored by Aimen F. Shaaban, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05450653 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Diaphragmatic Hernia
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Where NCT05450653'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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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
-
Safety and Efficacy of FETO in CDH: A Phase III Trial
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
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-
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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