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NCT02710968 · ClinicalTrials.gov registry record · NA
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
A NA study of Congenital Diaphragmatic Hernia, sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT02710968 is a NA study of Congenital Diaphragmatic Hernia that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 21 participants, below the 195-participant average among 22 other Congenital Diaphragmatic Hernia trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02710968, a NA study of Congenital Diaphragmatic Hernia, is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with congenital diaphragmatic hernia (CDH) remain high. The survival relates to the degree of prenatal lung compression and the subsequent impairment of pulmonary function following delivery. Prenatal assessment by ultrasound or magnetic resonance imaging allows to estimate the severity by relating the circumference of the lung contralateral to the hernia to the fetal head circumference lung to head ratio (LHR) and by noting the degree of upward herniation of the liver. Based on the observed to expected lung to head ratio (O/E LHR), prenatally diagnosed congenital diaphragmatic hernia can be prognostically assessed. While overall survival of congenital diaphragmatic hernia is approximately 60%, an O/E LHR \<25% is associated with survival between 11-24%. The rationale for fetal therapy in severe congenital diaphragmatic hernia is to restore adequate lung growth for neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed intrauterine endoscopic techniques (fetoscopy) to position and remove endoluminal tracheal balloons in utero (fetoscopic endotracheal occlusion = FETO). Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%. We hypothesize that FETO can be performed and may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe CDH in the most severe group of fetuses with left CDH (O/E LHR \< 30%). FETO therapy will be considered in two subgroups: those with and O/E LHR \<
Conditions Studied
Interventions
- DEVICE 11540KE and Balt Goldbal 2 balloon
Study Locations (1)
Maryland
- Johns Hopkins Center for Fetal Therapy - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-08 |
| Est. Completion | 2028-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02710968
The ClinicalTrials.gov registry entry for NCT02710968 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 21 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 (89% lower). The listed sponsor is Johns Hopkins University, which has 1,448 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 11540KE and Balt Goldbal 2 balloon is the first listed.
NCT02710968 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02710968 about?
NCT02710968 is a clinical study titled "Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)". Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with congenital diaphragmatic hernia (C...
What is the current status of trial NCT02710968?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 21 participants. The study started on 2015-08. Estimated completion is 2028-03.
What conditions does trial NCT02710968 study?
This clinical trial studies the following conditions: Congenital Diaphragmatic Hernia.
What interventions are being tested in trial NCT02710968?
The interventions under investigation include: 11540KE and Balt Goldbal 2 balloon (DEVICE).
Who is sponsoring clinical trial NCT02710968?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02710968 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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