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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 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.

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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).

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

Sponsor

Inna Lobeck

1 total trials

What the Registry Record Tells You About NCT06179472

The ClinicalTrials.gov registry entry for NCT06179472 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 195-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (90% lower). The listed sponsor is Inna Lobeck, 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 GOLDBAL2 Balloon is the first listed.

NCT06179472 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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