Congenital Diaphragmatic HerniaCHOP FETONCT06884423
Safety and Efficacy of FETO in CDH: A Phase III Trial
A study testing FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Holly L Hedrick, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
- What is being tested?
- FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to Apr 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 26 weeks.
- Gestational age at enrollment is prior to 29 weeks 6 days
- Liver is intrathoracic
- Isolated left congenital diaphragmatic hernia (CDH) with observed/expected lung to head ratio (O/E LHR) of less than 30% at enrollment (18^0 to 29^5 weeks), or:
Show all 10Show fewer
- Isolated right CDH with O/E LHR equal to or less than 45% at enrollment (18^0 to 29^5 weeks).
- Cervical length by transvaginal ultrasound equal to or greater than 20 mm within 24 hours of fetoscopic endoluminal tracheal occlusion (FETO) procedure
- Patient meets psychosocial criteria
- Informed consent
Who cannot join
- Patient is less than 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minutes of the Children's Hospital of Philadelphia (CHOP) and inability to comply with the travel for the follow-up requirements of the trial
Show all 18Show fewer
- Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at CHOP
- Bilateral CDH, isolated left sided CDH with O/E LHR greater than or equal to 30% (measured at 18^0 to 29^5 weeks), isolated right sided CDH with O/E LHR greater than 45% (measured at 180 to 295 weeks), as determined by ultrasound
- No Liver herniation into thoracic cavity.
- Additional fetal anomaly by ultrasound, magnetic resonance imaging (MRI), or echocardiogram at the fetal treatment center. Exclude chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (ie. CDH and congenital heart disease) or presence of an underlying genetic syndrome (ie. Fryns).
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accrete) known at time of enrollment.
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment.
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- There is no safe or technically feasible fetoscopic approach to balloon placement.
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Annaliese Aarthun contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Holly L Hedrick, MD, FACS, 1-800-468-8376, hedrick@chop.edu
Annaliese Aarthun, aarthuna@chop.edu
About this study
Official title: Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial
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.
Read the detailed description
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.
- Being tested
- FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter
- Keywords
- congenital diaphragmatic hernia, tracheal occlusion
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FETO with GoldBAL2 Balloon and BALTACCIBDPE100 CatheterDevice
Fetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter
| Study group | Role | What they receive |
|---|---|---|
| FETO in CDH | Experimental | 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. Receives: Device: FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter |
| Expectant Management in CDH | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Measured: 24 months
Assessment of complications associated with the FETO intervention
Evaluate the frequency of maternal and fetal complications associated with the FETO intervention.
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start7 Apr 2025
- Primary completionApr 2030 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holly L Hedrick, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Holly L Hedrick, MD, Children's Hospital of Philadelphia
- Investigators
- Holly L Hedrick, MD, FACS, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884423
- Sponsor's protocol ID
- 24-022603
- Other IDs
- G140236
- Acronym
- CHOP FETO
- Status last verified
- Jul 2026
- First submitted
- 13 Mar 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
Danzer E, Hedrick HL. Controversies in the management of severe congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2014 Dec;19(6):376-84. doi: 10.1016/j.siny.2014.10.001. Epub 2014 Nov 7.
PubMed 25454678Deprest JA, Gratacos E, Nicolaides K, Done E, Van Mieghem T, Gucciardo L, Claus F, Debeer A, Allegaert K, Reiss I, Tibboel D. Changing perspectives on the perinatal management of isolated congenital diaphragmatic hernia in Europe. Clin Perinatol. 2009 Jun;36(2):329-47, ix. doi: 10.1016/j.clp.2009.03.004.
PubMed 19559323Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.
PubMed 19658113Style CC, Olutoye OO, Belfort MA, Ayres NA, Cruz SM, Lau PE, Shamshirsaz AA, Lee TC, Olutoye OA, Fernandes CJ, Cortes MS, Keswani SG, Espinoza J. Fetal endoscopic tracheal occlusion reduces pulmonary hypertension in severe congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2019 Dec;54(6):752-758. doi: 10.1002/uog.20216. Epub 2019 Nov 4.
PubMed 30640410Russo FM, Cordier AG, Basurto D, Salazar L, Litwinska E, Gomez O, Debeer A, Nevoux J, Patel S, Lewi L, Pertierra A, Aertsen M, Gratacos E, Nicolaides KH, Benachi A, Deprest J. Fetal endoscopic tracheal occlusion reverses the natural history of right-sided congenital diaphragmatic hernia: European multicenter experience. Ultrasound Obstet Gynecol. 2021 Mar;57(3):378-385. doi: 10.1002/uog.23115.
PubMed 32924187Deprest JA, Nicolaides KH, Benachi A, Gratacos E, Ryan G, Persico N, Sago H, Johnson A, Wielgos M, Berg C, Van Calster B, Russo FM; TOTAL Trial for Severe Hypoplasia Investigators. Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia. N Engl J Med. 2021 Jul 8;385(2):107-118. doi: 10.1056/NEJMoa2027030. Epub 2021 Jun 8.
PubMed 34106556Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11.
PubMed 25447987
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial
- ClinicalTrials.gov ID
- NCT06884423
- Acronym / sponsor ID
- CHOP FETO / 24-022603
- Keywords
- congenital diaphragmatic hernia, tracheal occlusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Holly L Hedrick, MDUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2032 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FETO in CDH | Experimental | Device: FETO with GoldBAL2 Balloon and BALTACCIBDPE100 CatheterFetoscopic 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. |
| Expectant Management in CDH | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pregnant women age 18 years and older
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results, whole exome sequencing (WES), whole genome sequencing (WGS), or chromosomal microarray with non-pathologic variants. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 26 weeks.
- Gestational age at enrollment is prior to 29 weeks 6 days
- Liver is intrathoracic
Key exclusion criteria (18 listed)
- Patient is less than 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (less than 20 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FETO with GoldBAL2 Balloon and BALTACCIBDPE100 CatheterFetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter | Device | FETO in CDH |
Primary outcome
Successful placement and removal of the FETO Device
Time frame: 24 months
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%.
Comparison of neonatal survival rates of LCDH cases between intervention and control groups
Time frame: 24 months
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.
Comparison of neonatal survival rates of RCDH cases between intervention and control groups
Time frame: 24 months
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.
Assessment of complications associated with the FETO intervention
Time frame: 24 months
Evaluate the frequency of maternal and fetal complications associated with the FETO intervention.
2 secondary outcomes
Comparison of long-term mortality and morbidity of LCDH cases between intervention and control groups
Time frame: 24 months
Comparison of long-term mortality and morbidity of RCDH cases between intervention and control groups
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 25454678Danzer E, Hedrick HL. Controversies in the management of severe congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2014 Dec;19(6):376-84. doi: 10.1016/j.siny.2014.10.001. Epub 2014 Nov 7.
- Background: PubMed 19559323Deprest JA, Gratacos E, Nicolaides K, Done E, Van Mieghem T, Gucciardo L, Claus F, Debeer A, Allegaert K, Reiss I, Tibboel D. Changing perspectives on the perinatal management of isolated congenital diaphragmatic hernia in Europe. Clin Perinatol. 2009 Jun;36(2):329-47, ix. doi: 10.1016/j.clp.2009.03.004.
- Background: PubMed 19658113Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.
- Background: PubMed 30640410Style CC, Olutoye OO, Belfort MA, Ayres NA, Cruz SM, Lau PE, Shamshirsaz AA, Lee TC, Olutoye OA, Fernandes CJ, Cortes MS, Keswani SG, Espinoza J. Fetal endoscopic tracheal occlusion reduces pulmonary hypertension in severe congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2019 Dec;54(6):752-758. doi: 10.1002/uog.20216. Epub 2019 Nov 4.
- Background: PubMed 32924187Russo FM, Cordier AG, Basurto D, Salazar L, Litwinska E, Gomez O, Debeer A, Nevoux J, Patel S, Lewi L, Pertierra A, Aertsen M, Gratacos E, Nicolaides KH, Benachi A, Deprest J. Fetal endoscopic tracheal occlusion reverses the natural history of right-sided congenital diaphragmatic hernia: European multicenter experience. Ultrasound Obstet Gynecol. 2021 Mar;57(3):378-385. doi: 10.1002/uog.23115.
- Background: PubMed 34106556Deprest JA, Nicolaides KH, Benachi A, Gratacos E, Ryan G, Persico N, Sago H, Johnson A, Wielgos M, Berg C, Van Calster B, Russo FM; TOTAL Trial for Severe Hypoplasia Investigators. Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia. N Engl J Med. 2021 Jul 8;385(2):107-118. doi: 10.1056/NEJMoa2027030. Epub 2021 Jun 8.
- Background: PubMed 25447987Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11.
- CHOP Center for Fetal Diagnosis and TreatmentLink provided by the sponsor.
- CHOP Pulmonary Hypoplasia ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Congenital Diaphragmatic Hernia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annaliese Aarthun contact
Holly L Hedrick, MD, FACS principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FETO with GoldBAL2 Balloon and BALTACCIBDPE100 Catheter in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Holly L Hedrick, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly L Hedrick, MD, FACS (1-800-468-8376, hedrick@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful placement and removal of the FETO Device (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884423, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.