Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
NCT ID: NCT05962346
Last Updated: 2025-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2026-01-31
2043-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FETO Group
Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.
BALT GOLDBALL 2 detachable latex ballon
Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
BALTACCIBDPE100 Microcatheter
Used to deliver the detachable balloon
Storz fetoscopic operating sheath and miniature telescope/fetoscope
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.
Interventions
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BALT GOLDBALL 2 detachable latex ballon
Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
BALTACCIBDPE100 Microcatheter
Used to deliver the detachable balloon
Storz fetoscopic operating sheath and miniature telescope/fetoscope
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Mauro H. Schenone
OTHER
Responsible Party
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Mauro H. Schenone
Regulatory Sponsor and Principal Investigator
Principal Investigators
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Mauro Schenone, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Minnesota
Rochester, Minnesota, United States
Countries
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Facility Contacts
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Mauro H. Schenone, MD
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-002166
Identifier Type: -
Identifier Source: org_study_id