Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

This study is looking at a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. This procedure uses a BALT GOLDBALL 2 detachable latex balloon, delivered with a BALTACCIBDPE100 Microcatheter and Storz fetoscopic operating sheath, to help the lungs of babies with severe congenital diaphragmatic hernia (CDH) grow better before birth. The study aims to see how safe and effective this procedure is. Researchers will measure if the balloon is placed and removed successfully, and how long these procedures take. You may be able to join if you are a woman between 18 and 50 years old, have a single pregnancy, and your baby has severe left CDH with specific lung measurements. Your baby must also have a normal genetic test and be less than 29 weeks and 6 days pregnant at enrollment. The study plans to enroll 20 participants, but its current status is unclear.

Study design: This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study measures technical success of balloon placement up to 29 weeks gestation and balloon retrieval and operative times up to 34 weeks gestation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Recruiting

NAAges 18–50InterventionalTreatment

Mauro H. Schenone

~20 participants

Updated 2026-03-19 on ClinicalTrials.gov

What's tested:BALT GOLDBALL 2 detachable latex ballonBALTACCIBDPE100 MicrocatheterStorz fetoscopic operating sheath and miniature telescope/fetoscope

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Technical success of the balloon placement procedure

Measured over Up to 29 weeks gestation

+5 more outcomes measured

Conditions

Congenital Diaphragmatic Hernia

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Mauro Schenone, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Mauro H. Schenone, MD

507-293-4390

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

Exclusion

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

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

What this trial measures

Technical success of the balloon placement procedureUp 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 procedureUp to 34 weeks gestation
The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
Operative timesUp to 34 weeks gestation
FETO placement and release operative times reported in minutes
Frequency of unplanned balloon removalUp to 34 weeks gestation
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
Number of incidences of maternal complicationsUp to 41 weeks gestation
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Gestational Age at DeliveryUp to 41 weeks gestation
Gestation Age reported at time of delivery

Trialytics