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NCT02549820 · ClinicalTrials.gov registry record · NA
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
A NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, sponsored by Children's Hospital of Philadelphia.
- Active
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02549820: Active NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, sponsored by Children's Hospital of Philadelphia.
NCT02549820 is a NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia that is active but no longer recruiting, run by Children's Hospital of Philadelphia. The registered enrollment target is 14 participants, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02549820, a NA study of Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, is active but no longer recruiting, sponsored by Children's Hospital of Philadelphia.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other 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.
Primary Outcome
Successful balloon placement and removal will be counted per patient. FETO insertion will be attempted up to 3 times in a single pregnant woman/ fetus. The maximum duration of balloon implantation, if placed at 27 weeks 0 days and removed in the 34th week, is 7 weeks. For those balloons placed later in gestation or removed earlier electively or emergently, the duration will be shorter.
Conditions Studied
Interventions
- DEVICE GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-07 |
| Est. Completion | 2027-07 |
| Phase | NA |
What the registry record for NCT02549820 still lists
NCT02549820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 196-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Congenital Diaphragmatic Hernia appearing as the primary indexed condition, and to 1 intervention - of which GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter is the first listed.
NCT02549820 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02549820 about?
NCT02549820 is a clinical study titled "Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia". CDH is a birth defect characterized by the development, very early in gestation, of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, the intestines and other organs in the abdomen can move into the chest and press on the developing lungs. This pre...
What is the current status of trial NCT02549820?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 14 participants. The study started on 2015-07. Estimated completion is 2027-07.
What conditions does trial NCT02549820 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia.
What interventions are being tested in trial NCT02549820?
The interventions under investigation include: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter (DEVICE).
Who is sponsoring clinical trial NCT02549820?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02549820 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT02549820's enrollment target sits among peer trials
14 17th of 22 higher than 6 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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Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
RECRUITING · NA
-
Safety and Efficacy of FETO in CDH: A Phase III Trial
RECRUITING · NA
-
Trial of FETO for Severe Congenital Diaphragmatic Hernia
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for CDH (CDH)
RECRUITING · NA
-
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
RECRUITING · NA
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