An interventional study of Fetal Tracheal Occlusion in Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia and Pulmonary; Hypertension, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Children's Hospital Medical Center, Cincinnati · 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 13th largest by planned enrollment of the 36 interventional ones that give a count, is the only one that started in 2016, is one of 28 with no phase, reaches primary completion later than 3 of the 27 other live ones, and was the 16th 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 to 50 Years · female · healthy volunteers too.
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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. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is above 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:
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 129 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Children's Hospital Medical Center, Cincinnati 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.
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of \<25%, LHR \<1, or a moderate category with o/e LHR \<30%, singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days (severe), gestational age \< 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old.... meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth.
Device: Fetal Tracheal Occlusion
Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of \<25%, LHR \<1, o/e LHR\<30% (moderate), singleton pregnancy, no known other anomalies, gestational age \< 29 weeks 6 days, no maternal disease, maternal age \> 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.
Also known as: FETO, Fetal Endoluminal Tracheal Occlusion
Change lung growth on prenatal imaging
Change in o/eLHR and other prenatal imaging tests
Time frame: prenatal period up to 40 weeks gestation
Change survival in the severe congenital diaphragmatic hernia subgroup
Change rate of survival
Time frame: 6 months
Change need for ECMO therapy
Change need for ECMO therapy
Time frame: 6 months
Change pulmonary hypertension
Change pulmonary hypertension
Time frame: 6 months
Change neonatal morbidity
Change neonatal morbidity
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Dec 2025, 109 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 109 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Hernias, Diaphragmatic, Congenital →
Children's Hospital Medical Center, Cincinnati →