NCT02530073|RecruitingDMCFDA Device
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
FETO
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
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Sponsor study identifier
interventional
15
1 country
1
Study Start
September 2015
Actual (reported)Primary Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 31, 2015
Actual (reported)August 20, 2015
Actual (reported)September 2015
Actual (reported)August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percent of neonatal survivors at time of discharge
Feasibility, safety, and survival rates of the FETO procedure
Discharge from the hospital, an expected average of 12 weeks.
Prenatal increase in lung volume
2 weeks (prenatally)
Number of days of Postnatal mechanical ventilator support
First 28 days of postnatal life
Changes in RNA content of tracheal and amniotic fluid
At time of balloon placement and removal
Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid
At time of balloon placement and removal
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio \<25% (O/E LHR).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Timothy Crombleholme, MD
Connecticut Children's Medical Center
First Submitted
July 31, 2015
First Posted
August 20, 2015
Study Start
September 2015
Actual (reported)Primary Completion
August 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 18, 2026
Record last verified: 2026-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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