FETO Group for Morgagni Hernias

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FL
Morgagni Hernias+5 More
BALT GoldbBAL2 Detachable Balloon - Device
Eligibility
18 - 65
Female
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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

1 of 3

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

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
Photo of University of Miami  1Photo of University of Miami  2Photo of University of Miami  3
1991First Recorded Clinical Trial
0 TrialsResearching Morgagni Hernias
619 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 6 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.