Congenital Diaphragmatic HerniaFETONCT04052828
Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)
A study testing FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) in people with Congenital Diaphragmatic Hernia, run by Dr Erin Perrone at 1 site in United States.
Trial summary
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 16 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed and dated consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Singleton pregnancy
- No pathogenic variants on microarray or pathologic findings on karyotype
- Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
- Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as observed-to-expected (o/e) lung to head ratios (LHR) <25% with liver up
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- Gestational age at FETO procedure: if o/e LHR <25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
- Meets psychosocial criteria
- Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
- Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Von Voigtlander Women's Hospital
- Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work.
Who cannot join
- Multi-fetal pregnancy
- History of latex allergy
- History of preterm labor or incompetent cervix (requiring cerclage), short cervix (≤20mm), or uterine anomaly predisposing to preterm labor
- Bilateral CDH, unilateral CDH with o/e LHR > 25%, or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
- Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
- Maternal contraindications to elective fetoscopic surgery
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- Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
- Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
- No safe or feasible fetoscopic approach to balloon placement
- Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal Endoscopic Tracheal Occlusion Trial for Congenital Diaphragmatic Hernia (CDH)
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine.
This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.
Read the detailed description
This study has concluded and the second FETO trial (NCT07577414) has begun enrolling participants.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
- Keywords
- pregnant, fetal endoscopic 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 Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)Device
This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
| Study group | Role | What they receive |
|---|---|---|
| FETO with GOLDBAL2 | Experimental | A balloon will be placed in the airway of the fetus during the FETO procedure. Receives: Device: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Placement of the Goldballoon Detachable Balloon (GOLDBAL2) at Gestational Age 27 Weeks Zero Days (27w0d) to 29 Weeks and 6 Days (29w6d) Gestation.
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Measured: Between 27 weeks 0 days and 29 week 6 days of gestation, within 1 week of enrollment
Number of Participants With Successful Retrieval of the GOLDBAL2
This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery. Alternatively, it could occur on placental bypass.
Measured: Removal prior to delivery approximately 34 weeks of gestation (up to approximately 8 weeks post enrollment) or at delivery on placental bypass (up to approximately 14 weeks post enrollment)
Secondary outcomes (5)
Change in Observed to Expected Total Fetal Lung Volume (o/e TFLV) on Prenatal Magnetic Resonance Imaging (MRI)
Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval. Observed to expected total fetal lung volume (o/e TFLV) is the percentage of lung volume a fetus has compared to the expected lung volume for a fetus at the same gestational age. It is calculated by dividing the observed TFLV by the expected TFLV and multiplying by 100 to get a percent. This outcome measure is the median change in o/e TFLV between the MRIs.
Measured: baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval (approximately 11 weeks post enrollment)
Change in Fetal Lung Growth
Fetal ultrasounds will be done weekly while the balloon is in place. Fetal lung growth will be calculated as the difference between the observed to expected Lung to Head Ratio (o/e LHR) pre-balloon placement and the o/e LHR immediately prior to balloon removal. O/e LHR uses the area of the lung opposite of the diaphragmatic hernia divided by head circumference to get a lung to head ratio. The observed to expected lung to head ratio is the lung to head ratio divided by the expected lung to head ratio at that gestational age multiplied by 100 to get a percent. This outcome measure describes the change in o/e LHR.
Measured: baseline (before balloon placement), immediately prior to balloon removal (up to approximately 14 weeks post enrollment)
Gestational Age at Delivery
Measured: At the time of delivery (up to approximately 14 weeks post enrollment)
Survival of Infant to Hospital Discharge or 180 Days After Hospitalized
This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point.
Measured: Discharge from hospital or up to 180 days in the hospital (up to approximately 40 weeks post enrollment)
Number of Participants With Maternal Complications
Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection. In results, patients who experience PPROM are also counted for PROM.
Measured: up to 4-8 weeks postpartum (up to approximately 22 weeks post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start5 Apr 2021
- Primary completion12 Aug 2025
- Study completion16 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Erin Perrone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Erin Perrone, University of Michigan
- Investigators
- Erin Perrone, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052828
- Sponsor's protocol ID
- HUM00159792
- Acronym
- FETO
- Status last verified
- Nov 2026
- First submitted
- 8 Aug 2019
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Endoscopic Tracheal Occlusion Trial for Congenital Diaphragmatic Hernia (CDH)
- ClinicalTrials.gov ID
- NCT04052828
- Acronym / sponsor ID
- FETO / HUM00159792
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- pregnant, fetal endoscopic tracheal occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Dr Erin PerroneUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine.
This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.
Detailed description
This study has concluded and the second FETO trial (NCT07577414) has begun enrolling participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FETO with GOLDBAL2 | Experimental | Device: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)A balloon will be placed in the airway of the fetus during the FETO procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed and dated consent
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Singleton pregnancy
- No pathogenic variants on microarray or pathologic findings on karyotype
- Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
Key exclusion criteria (11 listed)
- Multi-fetal pregnancy
- History of latex allergy
- History of preterm labor or incompetent cervix (requiring cerclage), short cervix (≤20mm), or uterine anomaly predisposing to preterm labor
- Bilateral CDH, unilateral CDH with o/e LHR > 25%, or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
- Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
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 Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation. | Device | FETO with GOLDBAL2 |
Primary outcome
Number of Participants With Successful Placement of the Goldballoon Detachable Balloon (GOLDBAL2) at Gestational Age 27 Weeks Zero Days (27w0d) to 29 Weeks and 6 Days (29w6d) Gestation.
Time frame: Between 27 weeks 0 days and 29 week 6 days of gestation, within 1 week of enrollment
Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.
Number of Participants With Successful Retrieval of the GOLDBAL2
Time frame: Removal prior to delivery approximately 34 weeks of gestation (up to approximately 8 weeks post enrollment) or at delivery on placental bypass (up to approximately 14 weeks post enrollment)
This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery. Alternatively, it could occur on placental bypass.
5 secondary outcomes
Change in Observed to Expected Total Fetal Lung Volume (o/e TFLV) on Prenatal Magnetic Resonance Imaging (MRI)
Time frame: baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval (approximately 11 weeks post enrollment)
Change in Fetal Lung Growth
Time frame: baseline (before balloon placement), immediately prior to balloon removal (up to approximately 14 weeks post enrollment)
Gestational Age at Delivery
Time frame: At the time of delivery (up to approximately 14 weeks post enrollment)
Survival of Infant to Hospital Discharge or 180 Days After Hospitalized
Time frame: Discharge from hospital or up to 180 days in the hospital (up to approximately 40 weeks post enrollment)
Number of Participants With Maternal Complications
Time frame: up to 4-8 weeks postpartum (up to approximately 22 weeks post enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Erin Perrone, MD principal investigator
University of Michigan
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 Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) in people with Congenital Diaphragmatic Hernia, run by Dr Erin Perrone 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 11 inclusion and 11 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: finished, as of the sponsor's last update on 4 Nov 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?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Placement of the Goldballoon Detachable Balloon (GOLDBAL2) at Gestational Age 27 Weeks Zero Days (27w0d) to 29 Weeks and 6 Days (29w6d) Gestation. (time frame: Between 27 weeks 0 days and 29 week 6 days of gestation, within 1 week of enrollment). The study lists 2 primary outcomes in all. 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 4 Nov 2026.