Congenital Diaphragmatic HerniaFETONCT05962346
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
A study testing BALT GOLDBALL 2 detachable latex ballon, BALTACCIBDPE100 Microcatheter and Storz fetoscopic operating sheath and miniature telescope/fetoscope in people with Congenital Diaphragmatic Hernia, run by Mauro H. Schenone at 1 site in United States.
Trial summary
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- BALT GOLDBALL 2 detachable latex ballon, BALTACCIBDPE100 Microcatheter and Storz fetoscopic operating sheath and miniature telescope/fetoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jul 2043
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- Isolated severe left CDH with O/E LHR < 25% )
- Gestation age at enrollment prior to 29 wks plus 6 days.
- Pulmonary hypoplasia with ultrasound O/E LHR < 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery.
- Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
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- Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic, Rochester and able to comply with the travel for the follow-up requirements of the trial; patient has a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic
- Patient is willing and able to give informed consent
- Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT)
Who cannot join
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<20 mm) at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor
- Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester and inability to comply with the travel for the follow-up requirements of the trial; 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 Mayo Clinic
- Right sided CDH or bilateral CDH, isolated left sided with O/E LHR >25% measured at 18 0/7 to 29 6/7 weeks) as determined by ultrasound
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
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- Maternal contraindication to fetoscopic surgery
- 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 status positive.
- Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality that will make the procedure technically unfeasible
- 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
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Mauro H. Schenone, MD, 507-293-4390
About this study
Official title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- BALT GOLDBALL 2 detachable latex ballon, BALTACCIBDPE100 Microcatheter, Storz fetoscopic operating sheath and miniature telescope/fetoscope
- 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.
BALT GOLDBALL 2 detachable latex ballonDevice
Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
BALTACCIBDPE100 MicrocatheterDevice
Used to deliver the detachable balloon
Storz fetoscopic operating sheath and miniature telescope/fetoscopeDevice
Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.
| Study group | Role | What they receive |
|---|---|---|
| FETO Group | Experimental | Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation. Receives: Device: BALT GOLDBALL 2 detachable latex ballon; Device: BALTACCIBDPE100 Microcatheter; Device: Storz fetoscopic operating sheath and miniature telescope/fetoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the balloon placement procedure
The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.
Measured: Up to 29 weeks gestation
Technical success of balloon retrieval procedure
The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
Measured: Up to 34 weeks gestation
Operative times
FETO placement and release operative times reported in minutes
Measured: Up to 34 weeks gestation
Frequency of unplanned balloon removal
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Measured: Up to 34 weeks gestation
Number of incidences of maternal complications
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Measured: Up to 41 weeks gestation
Gestational Age at Delivery
Gestation Age reported at time of delivery
Measured: Up to 41 weeks gestation
Secondary outcomes (13)
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Volume as measured via ultrasound
Measured: Up to 24 months post partum
Fetal Lung Growth as measured via LHR
Lung area to head circumference Ratio (LHR) as measured via ultrasound
Measured: Up to 24 months post partum
Fetal Survival
Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized
Measured: Up to 6 months post partum
Fetal Oxygen Dependency
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Measured: Up to 24 months post partum
Occurrence of severe pulmonary hypertension
Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram
Measured: Up to 24 months post partum
ECMO Support
Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support
Measured: Up to 24 months post partum
Number of days in NICU
Number of days infant was in neonatal intensive care unit
Measured: Up to 24 months post partum
Number of days of ventilator support
Number of reported days infants required ventilator support
Measured: Up to 24 months post partum
Number of periventricular leukomalacia at < 2 months postnatally
Number of infants reported presence of periventricular leukomalacia at < 2 months postnatally
Measured: Up to 2 months post partum
Number of infant complications
Number of infants reporting the presence of: neonatal sepsis, intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher) or gastro-esophageal reflux
Measured: Up to 24 months post partum
Use of patch or muscle flap
Number of infants reported to require the use of patch or muscle flap
Measured: Up to 24 months post partum
Maternal hospitalization
Number of reported days of maternal hospitalization
Measured: Up to 24 months post partum
Route of delivery
Number of participants that delivered vaginally and via caesarean section
Measured: Day 1 (post partum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study startDec 2026 (estimated)
- Primary completionJul 2043 (estimated)
- Study completionJul 2043 (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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauro H. Schenone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauro H. Schenone, Mayo Clinic
- Investigators
- Mauro Schenone, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962346
- Sponsor's protocol ID
- 23-002166
- Acronym
- FETO
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2023
- Last updated
- 19 Mar 2026
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT05962346
- Acronym / sponsor ID
- FETO / 23-002166
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mauro H. SchenoneUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jul 2043 (estimated)
- Study completion
- Jul 2043 (estimated)
- First posted
- 27 Jul 2023 (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.
The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FETO Group | Experimental | Device: BALT GOLDBALL 2 detachable latex ballon, Device: BALTACCIBDPE100 Microcatheter, Device: Storz fetoscopic operating sheath and miniature telescope/fetoscopeParticipants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Singleton pregnancy
- Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
- Isolated severe left CDH with O/E LHR < 25% )
- Gestation age at enrollment prior to 29 wks plus 6 days.
- Pulmonary hypoplasia with ultrasound O/E LHR < 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery.
Key exclusion criteria (14 listed)
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<20 mm) at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor
- Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester and inability to comply with the travel for the follow-up requirements of the trial; 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 Mayo Clinic
- Right sided CDH or bilateral CDH, isolated left sided with O/E LHR >25% measured at 18 0/7 to 29 6/7 weeks) as determined by ultrasound
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 |
|---|---|---|
| BALT GOLDBALL 2 detachable latex ballonInflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth. | Device | FETO Group |
| BALTACCIBDPE100 MicrocatheterUsed to deliver the detachable balloon | Device | FETO Group |
| Storz fetoscopic operating sheath and miniature telescope/fetoscopeUsed to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion. | Device | FETO Group |
Primary outcome
Technical success of the balloon placement procedure
Time frame: Up to 29 weeks gestation
The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.
Technical success of balloon retrieval procedure
Time frame: Up to 34 weeks gestation
The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
Operative times
Time frame: Up to 34 weeks gestation
FETO placement and release operative times reported in minutes
Frequency of unplanned balloon removal
Time frame: Up to 34 weeks gestation
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Number of incidences of maternal complications
Time frame: Up to 41 weeks gestation
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Gestational Age at Delivery
Time frame: Up to 41 weeks gestation
Gestation Age reported at time of delivery
13 secondary outcomes
Fetal Lung Growth as measured via Fetal Lung Volume
Time frame: Up to 24 months post partum
Fetal Lung Growth as measured via LHR
Time frame: Up to 24 months post partum
Fetal Survival
Time frame: Up to 6 months post partum
Fetal Oxygen Dependency
Time frame: Up to 24 months post partum
Occurrence of severe pulmonary hypertension
Time frame: Up to 24 months post partum
ECMO Support
Time frame: Up to 24 months post partum
Number of days in NICU
Time frame: Up to 24 months post partum
Number of days of ventilator support
Time frame: Up to 24 months post partum
Number of periventricular leukomalacia at < 2 months postnatally
Time frame: Up to 2 months post partum
Number of infant complications
Time frame: Up to 24 months post partum
Use of patch or muscle flap
Time frame: Up to 24 months post partum
Maternal hospitalization
Time frame: Up to 24 months post partum
Route of delivery
Time frame: Day 1 (post partum)
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 19 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Mauro Schenone, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALT GOLDBALL 2 detachable latex ballon, BALTACCIBDPE100 Microcatheter and Storz fetoscopic operating sheath and miniature telescope/fetoscope in people with Congenital Diaphragmatic Hernia, run by Mauro H. Schenone 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 9 inclusion and 14 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 19 Mar 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the balloon placement procedure (time frame: Up to 29 weeks gestation). The study lists 6 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 19 Mar 2026.