Fetoscopic Surgery for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Eligibility Criteria

This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe right or left Congenital Diaphragmatic Hernia (CDH), where the liver has moved up. The baby must have severely underdeveloped lungs, confirmed by ultrasound measurements, and enrollment should be before 29 weeks plus 6 days of gestation.

Inclusion Criteria

My unborn baby has a normal chromosome analysis.

I am a pregnant woman, 18 or older, and can give consent.

Singleton pregnancy

Exclusion Criteria

Rubber latex allergy

I am pregnant and under 18.

I have a health condition that prevents me from having surgery during pregnancy.

Participant Groups

The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery on unborn babies with CDH. It involves placing a balloon in the airway to help lung growth by allowing fluid buildup. The safety and effectiveness of both the FETO procedure and its removal are being evaluated.

Group I: Fetuses with R- sided CDH with O/E LHR < 45% Experimental Treatment 1 Intervention

Fetuses with Right CDH (O/E LHR \< 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Group II: Fetuses with Left CDH (O/E LHR < 25%) Experimental Treatment 1 Intervention

Fetuses with Left CDH (O/E LHR \< 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Group III: Fetuses with L- sided CDH with O/E LHR <30%. Experimental Treatment 1 Intervention

Fetuses with Left CDH (O/E LHR \< 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Fetoscopic Endoluminal 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:

Children's Hospital Colorado Aurora, CO

Who Is Running the Clinical Trial?

University of Colorado, Denver Lead Sponsor

References