An interventional study of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernias, sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Connecticut Children's Medical Center · Not applicable, Interventional, and Treatment
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Among 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States — 24 open to participants now, 28 under way, 2 of them phase 3. Hernias, Diaphragmatic, Congenital · United States.
Among the 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States, this one is the 23rd largest by planned enrollment of the 36 interventional ones that give a count, is one of 4 that started in 2015, is one of 28 with no phase, reaches primary completion later than 11 of the 27 other live ones, and was the 10th registered.
86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.
Browse Hernias, Diaphragmatic, Congenital studies →24 of the 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States are open now. Recruiting first, the newest first:
Mauro H. Schenone · Sites in United States
Ages 18–50 · Women only
Dr Erin Perrone · Sites in United States
Ages 18+
Vincent Duron · Sites in United States
Ages 18+
The University of Texas Health Science Center, Houston · Sites in United States
Ages 0 mo–1 mo
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 18–50 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 32 Hernias, Diaphragmatic, Congenital studies recruiting now, 16 (50%) set no upper age limit and 16 (50%) stop at 75 or younger; 13 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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45 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 30 across 62 interventional studies indexed under Hernias, Diaphragmatic, Congenital.
Median enrollment 21 across the 36 interventional studies, 51 across the 8 observational. Of the 14 that completed or were terminated, 5 (36%) have results posted.
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None of the 45 has an industry lead sponsor. The 10 most frequent:
Connecticut Children's Medical Center is the lead sponsor of 59 studies on the registry; 13 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Connecticut Children's Medical Center has 1 study filed under Hernias, Diaphragmatic, Congenital — fewer than ten, so there is no comparison to draw.
2 of the studies in Hernias, Diaphragmatic, Congenital with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04583644Hanmin LeePilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) | 2027-04 |
| NCT00950118Columbia UniversityDiaphragmatic Hernia Research & Exploration, Advancing Molecular Science | 2027-09 |
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Among the 45 studies in Hernias, Diaphragmatic, Congenital with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
Prenatal tracheal occlusion (TO) 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 foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.
The goal of this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH Observed/expected lung-to-head ratio \< 25%(O/E LHR \< 25%).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Fetal
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
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).
Also known as: BALT GOLDBAL2 Tracheal Balloon Catheter system
Percent of neonatal survivors at time of discharge
Feasibility, safety, and survival rates of the FETO procedure
Time frame: Discharge from the hospital, an expected average of 12 weeks.
Prenatal increase in lung volume
Lung volume after FETO procedure
Time frame: 2 weeks (prenatally)
Number of days of Postnatal mechanical ventilator support
mechanical ventilator support will be monitored and recorded in days of use
Time frame: First 28 days of postnatal life
Changes in RNA content of tracheal and amniotic fluid
Describe how tracheal occlusion affects the RNA content of amniotic and tracheal fluid in CDH fetuses, and to correlate this transcriptomic profile to the degree of lung hypoplasia and fetal and neonatal clinical outcomes.
Time frame: At time of balloon placement and removal
Characterization of extracellular vesicles (EVs) and miRNAs in tracheal and amniotic fluid
To describe how extracellular vesicles (EVs) are derived from the amniotic and tracheal fluid of CDH patients before and after tracheal occlusion, and to determine whether the identified miRNAs of interest are intra- or extra-vesicular.
Time frame: At time of balloon placement and removal
Started Sep 2015 (actual). Primary completion is estimated for Aug 2028, 155 months after the start.
Of 40 interventional studies with no phase under Hernias, Diaphragmatic, Congenital, half reached primary completion within 108 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 133. This study's planned 155 months is above that.
How these figures are worked out, and which studies are left out of them.
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Hernias, Diaphragmatic, Congenital →
Connecticut Children's Medical Center