An interventional study of FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter in Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, sponsored by Holly L Hedrick, MD. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Holly L Hedrick, MD · 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 4th largest by planned enrollment of the 36 interventional ones that give a count, is one of 7 that started in 2025, is one of 28 with no phase, reaches primary completion later than 19 of the 27 other live ones, and was the 38th 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. 7 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 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:
This is the only study on the registry with Holly L Hedrick, MD as lead sponsor.
Holly L Hedrick, MD 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:
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Congenital diaphragmatic hernia (CDH) is a birth defect characterized by the development of a hole in the diaphragm, the breathing muscle that separates the chest from the abdomen. As a result, organs in the abdomen can move into the chest and press on the developing lungs. This prevents the lungs from growing and developing normally.
In severe cases, CDH can lead to serious disease and death at birth. For these babies, treatment before birth may allow the lungs to grow enough before birth so these children are capable of surviving and thriving.
All patients will complete a standard prenatal evaluation at the Children's Hospital of Philadelphia (CHOP) Center for Fetal Diagnosis and Treatment (CFDT) to determine if they are candidates for this study. The standard clinical assessments include medical history and physical exam, level II ultrasound, fetal echocardiogram, fetal magnetic resonance imaging (MRI), and a psychosocial assessment.
If determined eligible for fetoscopic endoluminal tracheal occlusion (FETO) intervention, patients will be extensively counseled by the CFDT Team and those who choose to participate will provide written, informed consent for study enrollment.
Up to 40 maternal/fetal dyads will be enrolled in the intervention arm of this study. The pregnant patient and fetus will undergo two procedures. A balloon will be placed in the fetal airway between 27+0/7 - 29+6/7 gestational age. The balloon blocks the airway and remains in place until balloon removal. The timing for balloon removal will be determined by the CFDT Management Team and can occur between 34 +0/7 - 34+6/7 gestational age.
Pregnant patients enrolled in the intervention arm of study must remain near the fetal center, under close supervision, from the time of balloon placement through delivery in the CHOP Garbose Family Special Delivery Unit.
Weekly prenatal monitoring will occur after the first procedure at the CFDT, and planned delivery will occur in the Garbose Family Special Delivery Unit at term.
Postnatal stabilization and subsequent surgery to repair the diaphragm will take place at CHOP.
Up to 40 maternal/fetal dyads which meet criteria according to defect side, observed/expected lung to head ratio (O/E LHR), and liver position, but undergo expectant management rather than FETO intervention, will be enrolled in the control arm of this study.
Infants in both the intervention arm and the control arm will be followed at CHOP at 6 months, 12 months, 18 months, and 24 months of age through the CHOP Pulmonary Hypoplasia Program.
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:
Psychosocial ineligibility, precluding consent:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Fetoscopic Endoluminal Tracheal Occlusion (FETO) will be performed by placing a detachable balloon inside the fetal airway and removing the balloon after several weeks. Devices: GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.
Device: FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
The control arm includes patients eligible for FETO according to side of defect, O/E LHR, and liver position who undergo expectant management rather than FETO intervention. Assignment will be non-randomized. 40 maternal/fetal dyads will be enrolled in this arm.
Fetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter
Successful placement and removal of the FETO Device
Evalutation of successful placement and removal of the fetoscopic endoluminal tracheal occlusion (FETO) device in cases of intrathoracic liver herniation with isolated left congenital diaphragmatic hernia (LCDH) with observed/expected lung to head ratio (O/E LHR) \< 30% or isolated right congenital diaphragmatic hernia (RCDH) with O/E LHR \< 45%.
Time frame: 24 months
Comparison of neonatal survival rates of LCDH cases between intervention and control groups
Compare survival to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation and isolated LCDH with O/E LHR \< 30% that receive FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated LCDH and O/E LRH \< 30% that undergo expectant management.
Time frame: 24 months
Comparison of neonatal survival rates of RCDH cases between intervention and control groups
Compare the neonatal survival rate to discharge from the neonatal intensive care units (NICU), between fetuses with intrathoracic liver herniation, isolated RCDH with O/E LHR \< 45% that undergo FETO procedure performed at 27\^0 to 29\^6 weeks gestation to concurrent patients with intrathoracic liver herniation, isolated RCDH and O/E LHR \< 45% that proceed with expectant management.
Time frame: 24 months
Assessment of complications associated with the FETO intervention
Evaluate the frequency of maternal and fetal complications associated with the FETO intervention.
Time frame: 24 months
Comparison of long-term mortality and morbidity of LCDH cases between intervention and control groups
Evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities at 6, 12, 18 and 24 months in isolated LCDH survivors with O/E LHR \< 30% when compared to concurrent isolated LCDH with O/E LRH \< 30% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
Time frame: 24 months
Comparison of long-term mortality and morbidity of RCDH cases between intervention and control groups
Evaluate whether the FETO procedure is associated with reduced long-term mortality and morbidities at 6, 12, 18, and 24 months in isolated RCDH survivors with O/E LHR ≤ 45% when compared to concurrent isolated RCDH with LHR ≤ 45% that undergo expectant management where all fetuses were found to have intrathoracic liver herniation.
Time frame: 24 months
Plan to share: Yes — A deidentified data set will be shared with other NAFTNet institutions which perform FETO. These data will be shared under a data sharing agreement.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2030, 60 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 60 months is below that.
How these figures are worked out, and which studies are left out of them.
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Hernias, Diaphragmatic, Congenital →