Congenital Diaphragmatic HerniaPhase 3CDH FETONCT07187206
Safety and Efficacy of FETO in CDH Phase III
A Phase 3 study testing FETO, Fetal Endoluminal Tracheal Occlusion in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Hypertension
- What is being tested?
- FETO, Fetal Endoluminal Tracheal Occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 1 Mar 2033
- Phase
- Phase 3
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women 18 years and older, who are able to consent
- Singleton pregnancy
- Gestational age at enrollment is prior to 296 weeks
- Intrathoracic liver herniation
- Isolated Left CDH with o/e LHR < 30% at enrollment (180 to 295 weeks) or
- Isolated Right CDH with o/e LHR < 45% at enrollment (180 to 295 weeks)
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- Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- Cervical length by transvaginal ultrasound > 20 mm within 24 hours prior to FETO procedure
- Patient meets psychosocial criteria
- Informed consent understood
Who cannot join
- Patient < 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.
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- The 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 Cincinnati Children's Hospital Medical Center.
- Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR > 45%, as determined by ultrasound.
- No liver herniation into thoracic cavity
- Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accreta) 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 positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.
- Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure
- 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.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
Foong-Yen Lim, 513-803-5270, foong.yen.lim@cchmc.org
Erin Watters, 513-803-7024, erin.watters@cchmc.org
About this study
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
Read the detailed description
The purpose of this study is to demonstrate that the FETO procedure increases the neonatal survival to discharge and reduces long-term morbidity rates in fetuses found to have intrathoracic herniation of the liver with LCDH and o/e LHR < 30% or RCDH and o/e LHR < 45 % with intrathoracic liver herniation when compared to those that receive standard of care management that have comparable defects for side and fetal lung volumes estimates and intrathoracic liver herniation.
- Being tested
- FETO, Fetal Endoluminal Tracheal Occlusion
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FETO, Fetal Endoluminal Tracheal OcclusionDevice
Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia
| Study group | Role | What they receive |
|---|---|---|
| Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlu | Experimental | FETO balloon placement/removal Receives: Device: FETO, Fetal Endoluminal Tracheal Occlusion |
| Fetuses with severe or moderate congenital diaphragmatic hernia will receive standard of care and op | No intervention | no intervention standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change lung growth on prenatal imaging
Change in o/eLHR and other prenatal imaging tests
Measured: prenatal period up to 40 weeks gestation
Secondary outcomes (1)
Change survival in the severe congenital diaphragmatic hernia subgroup in intervention group
change rate of survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion1 Dec 2032 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187206
- Sponsor's protocol ID
- 2025-0362
- Acronym
- CDH FETO
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of FETO in CDH Phase III
- ClinicalTrials.gov ID
- NCT07187206
- Acronym / sponsor ID
- CDH FETO / 2025-0362
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2032 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 22 Sep 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.
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
Detailed description
The purpose of this study is to demonstrate that the FETO procedure increases the neonatal survival to discharge and reduces long-term morbidity rates in fetuses found to have intrathoracic herniation of the liver with LCDH and o/e LHR < 30% or RCDH and o/e LHR < 45 % with intrathoracic liver herniation when compared to those that receive standard of care management that have comparable defects for side and fetal lung volumes estimates and intrathoracic liver herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlu | Experimental | Device: FETO, Fetal Endoluminal Tracheal OcclusionFETO balloon placement/removal |
| Fetuses with severe or moderate congenital diaphragmatic hernia will receive standard of care and op | No intervention | –no intervention standard of care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Pregnant women 18 years and older, who are able to consent
- Singleton pregnancy
- Gestational age at enrollment is prior to 296 weeks
- Intrathoracic liver herniation
- Isolated Left CDH with o/e LHR < 30% at enrollment (180 to 295 weeks) or
Key exclusion criteria (18 listed)
- Patient < 18 years of age
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or 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, Fetal Endoluminal Tracheal OcclusionFetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia | Device | Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlu |
Primary outcome
Change lung growth on prenatal imaging
Time frame: prenatal period up to 40 weeks gestation
Change in o/eLHR and other prenatal imaging tests
1 secondary outcome
Change survival in the severe congenital diaphragmatic hernia subgroup in intervention group
Time frame: 6 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 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Congenital Diaphragmatic Hernia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
Congenital Diaphragmatic Hernia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FETO, Fetal Endoluminal Tracheal Occlusion in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Children's Hospital Medical Center, Cincinnati 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 Sep 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Foong-Yen Lim, MD ((513) 636-6259, Foong-Yen.Lim@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change lung growth on prenatal imaging (time frame: prenatal period up to 40 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.