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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: Recruiting NA study of Congenital Diaphragmatic Hernia, sponsored by Yair Blumenfeld.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DEVICE Balt "Goldballoon"

Study Locations (1)

California

  • Lucile Packard Children's Hospital - Stanford

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-04-17
Est. Completion 2030-08-31
Phase NA
Yair Blumenfeld

1 total trials

What NCT05461222 shows while recruiting

NCT05461222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (92% lower).

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 a single indexed study location in 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.

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 NCT05461222's enrollment target sits among peer trials

15 16th of 22 higher than 7 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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Source: ClinicalTrials.gov NCT05461222, the US trial registry maintained by the National Library of Medicine. NCT05461222 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.