Fetal Endotracheal Occlusion for Congenital Diaphragmatic Hernia

Palo Alto (17 mi)

Overseen byAlireza Shamshirsaz, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Alireza Shamshirsaz

No Placebo Group

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth. This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.

Eligibility Criteria

This trial is for pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia. Participants will be between 27 and nearly 30 weeks pregnant when undergoing the FETO procedure, and must be able to follow through with monitoring until their child turns two years old.

Inclusion Criteria

My condition involves a left-sided diaphragmatic hernia with liver displacement.

I am pregnant, over 18, and can give consent.

My genetic tests for chromosomes 13, 18, 21, X, and Y are normal.

My baby has severe lung underdevelopment with an O/E LHR less than 25%.

Exclusion Criteria

I have had a weak cervix, with or without a stitch.

I cannot stay at the hospital for the duration of the treatment and aftercare.

I am positive for HIV, Hepatitis B, or Hepatitis C.

I cannot have fetoscopic surgery due to uterine issues like fibroids.

I have a short cervix or a condition increasing my risk of early labor.

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

Treatment Details

The study tests the FETO procedure's ability to promote lung growth in fetuses with CDH before birth and improve survival rates after birth. It involves a small group of 10 participants who will have the device placed and then removed several weeks later.

1Treatment groups

Experimental Treatment

Group I: Fetal Endotracheal Occlusion (FETO)Experimental Treatment1 Intervention

Participants with severe congenital diaphragmatic hernia will undergo the FETO therapy.

Fetal Endotracheal Occlusion (FETO) is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as FETO for: