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NCT05461222 · ClinicalTrials.gov registry record · NA
Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
A NA study of Congenital Diaphragmatic Hernia, sponsored by Yair Blumenfeld.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05461222 is a NA study of Congenital Diaphragmatic Hernia that is actively recruiting participants, run by Yair Blumenfeld. The registered enrollment target is 15 participants, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05461222, a NA study of Congenital Diaphragmatic Hernia, is actively recruiting participants, sponsored by Yair Blumenfeld.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into the fetal trachea), manufactured by Balt medical. The investigators hope to study the risks and benefits of FETO in cases of severe CDH in an advanced medical center such as Lucile Packard Children's Hospital (LPCH) Stanford with access to advanced maternal-fetal medicine, neonatal services, and neonatal ECMO, and pediatric surgery.
Conditions Studied
Interventions
- DEVICE Balt "Goldballoon"
Study Locations (1)
California
- Lucile Packard Children's Hospital - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2030-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05461222
The ClinicalTrials.gov registry entry for NCT05461222 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 15 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 (92% lower). The listed sponsor is Yair Blumenfeld, 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 Balt "Goldballoon" is the first listed.
NCT05461222 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05461222 about?
NCT05461222 is a clinical study titled "Fetal Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia". The purpose of the study is to study the efficacy of fetal endoscopic tracheal occlusion (FETO) in cases of severe congenital diaphragmatic hernia (CDH). This study will also collect safety and effectiveness data for the off-label use of the FETO Goldballoon (the balloon that will be inserted into t...
What is the current status of trial NCT05461222?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2023-04-17. Estimated completion is 2030-08-31.
What conditions does trial NCT05461222 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.
What interventions are being tested in trial NCT05461222?
The interventions under investigation include: Balt "Goldballoon" (DEVICE).
Who is sponsoring clinical trial NCT05461222?
This trial is sponsored by Yair Blumenfeld, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05461222 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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