Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Mauro Schenone, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mauro H. Schenone

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for pregnant individuals with a fetus diagnosed with severe left-sided congenital diaphragmatic hernia (CDH) and poor lung development. Eligible participants must be able to give informed consent, have had appropriate counseling, carry a single pregnancy with normal fetal genetics, and be able to stay near the Mayo Clinic for the duration of the pregnancy.

Inclusion Criteria

Patient is willing and able to give informed consent

Singleton pregnancy

My unborn baby has a severe left-sided diaphragmatic hernia.

Exclusion Criteria

Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy

It's not safe or possible for me to have a balloon placed via fetoscopy.

Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Participant Groups

The trial tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using specialized instruments like a fetoscope and detachable balloon to improve lung growth in fetuses with CDH. The procedure's safety and effectiveness are being studied at Mayo Clinic.

Group I: FETO Group Experimental Treatment 3 Interventions

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

Fetal Endoscopic Tracheal Occlusion is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

🇪🇺 Approved in European Union as FETO for:

• Severe congenital diaphragmatic hernia (CDH)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Minnesota Rochester, MN

Who Is Running the Clinical Trial?

Mauro H. Schenone Lead Sponsor

References