FETO Group for Morgagni Hernias
Phase-Based Progress Estimates
Effectiveness
Safety
University of Miami, Miami, FL
Morgagni Hernias+5 More
BALT GoldbBAL2 Detachable Balloon - DeviceEligibility
18 - 65
Female
What conditions do you have?
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Eligibility
18 - 65
Female
What conditions do you have?
Select
Study Summary
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Eligible Conditions
- Morgagni Hernias
- Hypoplasia, Pulmonary
- Pulmonary Arterial Hypertension (PAH)
Treatment Effectiveness
Effectiveness Progress
Other trials for Morgagni Hernias
Study Objectives
6 Primary · 13 Secondary · Reporting Duration: Up to 24 months post partum
Day 1 (post partum)
Number of participants at each route of delivery
Month 24
Fetal survival
Number of days in neonatal intensive care unit
Number of days of Diaphragmatic Repair
Number of days of maternal hospitalization
Number of days of ventilator support
Number of infants reporting presence of complications
Number of infants requiring ECMO Support
Number of infants requiring the use of patch or muscle flap
Number of newborns reported at each oxygen dependency grading
Number of occurrence of severe pulmonary hypertension
Week 34
Frequency of unplanned balloon removal
Number of successfully completed FETO procedures
Operative time
Week 41
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Growth as measured via LHR
Gestational Age at Delivery
Number of incidences of maternal complications
Number of participants with maternal complications
Trial Safety
Safety Progress
Other trials for Morgagni Hernias
Trial Design
1 Treatment Group
FETO Group
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: FETO Group · No Placebo Group · N/A
FETO GroupExperimental Group · 2 Interventions: BALT GoldbBAL2 Detachable Balloon, Catheter System · Intervention Types: Device, Device
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months post partum
Closest Location: University of Miami · Miami, FL
1991First Recorded Clinical Trial
0 TrialsResearching Morgagni Hernias
619 CompletedClinical Trials
Eligibility Criteria
Age 18 - 65 · Female Participants · 6 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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