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NCT06179472 · ClinicalTrials.gov registry record · NA

Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

A NA study of Congenital Diaphragmatic Hernia, sponsored by Inna Lobeck.

Active
Registry status
NA
Development phase
20
Enrollment target
1
Study location

NCT06179472: Active NA study of Congenital Diaphragmatic Hernia, sponsored by Inna Lobeck.

NCT06179472 is a NA study of Congenital Diaphragmatic Hernia that is active but no longer recruiting, run by Inna Lobeck. The registered enrollment target is 20 participants, below the 195-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (90% 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

NCT06179472, a NA study of Congenital Diaphragmatic Hernia, is active but no longer recruiting, sponsored by Inna Lobeck.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children's Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right congenital diaphragmatic hernia (CDH).

Primary Outcome

Infant survival will be measured from delivery to discharge, at 6, 12, and 24 months of age.

Interventions

  • DEVICE BALT GOLDBAL2 Balloon

Study Locations (1)

Missouri

  • Children's Mercy Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-04-14
Est. Completion 2032-01-01
Phase NA
Inna Lobeck

1 total trials

What the registry record for NCT06179472 still lists

NCT06179472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 195-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which BALT GOLDBAL2 Balloon is the first listed.

NCT06179472 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT06179472 about?

NCT06179472 is a clinical study titled "Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial". The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children's Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrea...

What is the current status of trial NCT06179472?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-04-14. Estimated completion is 2032-01-01.

What conditions does trial NCT06179472 study?

This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.

What interventions are being tested in trial NCT06179472?

The interventions under investigation include: BALT GOLDBAL2 Balloon (DEVICE).

Who is sponsoring clinical trial NCT06179472?

This trial is sponsored by Inna Lobeck, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06179472 being conducted?

This trial has 1 study location across Missouri. 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 NCT06179472's enrollment target sits among peer trials

20 13th of 22 higher than 8 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 NCT06179472, the US trial registry maintained by the National Library of Medicine. NCT06179472 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.