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ACTIVE NOT RECRUITING NA

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

NCT06179472 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06179472

The ClinicalTrials.gov registry entry for NCT06179472 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inna Lobeck, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06179472 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06179472?

The interventions under investigation include: BALT GOLDBAL2 Balloon (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06179472?

This trial is sponsored by Inna Lobeck, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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