Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

NCT05962346 | Recruiting DMC FDA Device

• 1 other identifier: 23-002166
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  Up to 34 weeks gestation

• Operative times

  FETO placement and release operative times reported in minutes

  Up to 34 weeks gestation

• Frequency of unplanned balloon removal

  The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)

  Up to 34 weeks gestation

• Number of incidences of maternal complications

  Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

  Up to 41 weeks gestation

• Gestational Age at Delivery

  Gestation Age reported at time of delivery

  Up to 41 weeks gestation

Secondary Outcomes (13)

• Fetal Lung Growth as measured via Fetal Lung Volume

  Up to 24 months post partum

• Fetal Lung Growth as measured via LHR

  Up to 24 months post partum

• Fetal Survival

  Up to 6 months post partum

• Fetal Oxygen Dependency

  Up to 24 months post partum

• Occurrence of severe pulmonary hypertension

  Up to 24 months post partum

Study Arms (1)

FETO Group

EXPERIMENTAL

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

Device: BALT GOLDBALL 2 detachable latex ballon; Device: BALTACCIBDPE100 Microcatheter; Device: Storz fetoscopic operating sheath and miniature telescope/fetoscope

Interventions

BALT GOLDBALL 2 detachable latex ballon DEVICE

Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.

FETO Group

BALTACCIBDPE100 Microcatheter DEVICE

Used to deliver the detachable balloon

FETO Group

Storz fetoscopic operating sheath and miniature telescope/fetoscope DEVICE

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.

FETO Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mauro H. Schenone: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Interventions

Fetoscopes

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Mauro Schenone, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Sponsor and Principal Investigator

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2043
• Study Completion (Estimated): July 1, 2043
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)