Recruiting

Fetoscopic Endoluminal Tracheal Occlusion

Sponsor:

Mauro H. Schenone

Code:

NCT05962346

Conditions

Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

BALT GOLDBALL 2 detachable latex ballon

BALTACCIBDPE100 Microcatheter

Storz fetoscopic operating sheath and miniature telescope/fetoscope

Study Details

Brief 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).

Conditions

Congenital Diaphragmatic Hernia

Study ID

NCT05962346

Start date

Dec, 2026

Status verified date

Mar, 2026

Completion date

Jul, 2043

Anticipated

Primary completion date

Jul, 2043

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FETO Group

Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.

Interventions

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.

Primary outcome measure

  • Technical success of the balloon placement procedure [ Time Frame: Up to 29 weeks gestation ]
  • Technical success of balloon retrieval procedure [ Time Frame: Up to 34 weeks gestation ]
  • Operative times [ Time Frame: Up to 34 weeks gestation ]
  • Frequency of unplanned balloon removal [ Time Frame: Up to 34 weeks gestation ]
  • Number of incidences of maternal complications [ Time Frame: Up to 41 weeks gestation ]
  • Gestational Age at Delivery [ Time Frame: Up to 41 weeks gestation ]

Central Contacts and Locations

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Mauro H. Schenone, MD

507-293-4390

More Information

Sponsor

Mauro H. Schenone

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mauro H. Schenone on 2026-03-19.