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NCT06884423 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of FETO in CDH: A Phase III Trial
A NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, sponsored by Holly L Hedrick, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT06884423 is a NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia that is actively recruiting participants, run by Holly L Hedrick, MD. The registered enrollment target is 80 participants, below the 193-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (59% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06884423, a NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, is actively recruiting participants, sponsored by Holly L Hedrick, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study Summary
Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally. In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
Conditions Studied
Interventions
- DEVICE FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
Study Locations (2)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2032-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06884423
The ClinicalTrials.gov registry entry for NCT06884423 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (59% lower). The listed sponsor is Holly L Hedrick, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter is the first listed.
NCT06884423 reports 2 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06884423 about?
NCT06884423 is a clinical study titled "Safety and Efficacy of FETO in CDH: A Phase III Trial". Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs f...
What is the current status of trial NCT06884423?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-04-07. Estimated completion is 2032-04.
What conditions does trial NCT06884423 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia.
What interventions are being tested in trial NCT06884423?
The interventions under investigation include: FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter (DEVICE).
Who is sponsoring clinical trial NCT06884423?
This trial is sponsored by Holly L Hedrick, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06884423 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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