An interventional study of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by University of Colorado, Denver · 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 25th largest by planned enrollment of the 36 interventional ones that give a count, is one of 3 that started in 2018, is one of 28 with no phase, reaches primary completion later than 18 of the 27 other live ones, and was the 22nd 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. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 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.
This tab as a report to print or save as PDF → With an account.
None of the 45 has an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 2 studies 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 purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.
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 severe CDH remain high. Data from Children's Hospital of Philadelphia (CHOP) between January 2006 and December 2010 for prenatal and postnatal care for 64 patients with isolated left CDH showed overall survival was 63%. Survival was 33% in patients requiring the use ECMO. Immediate morbidity/mortality is related to the severity of the pulmonary hypoplasia caused by the mass effect of the herniated abdominal contents on the developing lungs. Quantifying the severity of pulmonary hypoplasia has been performed using the observed/expected lung to head circumference ratio (O/E LHR). It is a tool validated in 354 fetuses with unilateral isolated CDH evaluated between 18 and 38 weeks gestation. For O/E LHR \< 25%, survival was dismal at 1/9 or 11% (CHOP experience, not published). Published data from an interdisciplinary follow-up program at CHOP shows striking morbidities in neuromuscular tone and neurodevelopmental status.
The rationale for fetal therapy in severe CDH is to improve fetal lung growth and therefore 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 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 investigators goal with this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E\< 25%; O/E \< 30%) and right CDH (O/E \< 45%).
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.
Fetuses with Left CDH (O/E LHR \< 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Fetuses with Left CDH (O/E LHR \< 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Fetuses with Right CDH (O/E LHR \< 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
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 (O/E \< 25%; O/E LHR \< 30 %) and right CDH (O/E LHR \< 45%).
Also known as: BALT GOLDBALLOON: GoldBAL2 Detachable Balloon, BALTACCIBDPE100: Catheter System
Successful placement of Balt Goldbal2 balloon
The feasibility of performing the procedure and managing the pregnancy during the period of tracheal occlusion
Time frame: 7 weeks after placement
Successful removal of Balt Goldbal2 balloon
The feasibility of the removal of the device prior to delivery
Time frame: Within 5 weeks prior to delivery
Gestational age at delivery
Time frame: At delivery
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Maternal complications: preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis)
Time frame: After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)
Survival at Discharge or at 6 months if still hospitalized
Time frame: Discharge up to 180 days post delivery
Lung Volume Measurement
Time frame: 7 weeks after placement of balloon
Lung Head Ratio Measurement
Time frame: 7 weeks after placement of balloon
Plan to share: No
Started Nov 2018 (actual). Primary completion is estimated for Mar 2030, 136 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 136 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 →
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