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Procedure

Fetal Endotracheal Occlusion for Congenital Diaphragmatic Hernia

N/A
Waitlist Available
Led By Alireza Shamshirsaz, MD
Research Sponsored by Alireza Shamshirsaz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of isolated left CDH with liver up
Pregnant patient 18 and older who is able to consent
Must not have
History of incompetent cervix with or without cerclage
Inability to remain at FETO site during time period of tracheal occlusion, delivery, and postnatal care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years of age
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a procedure called Fetal Endotracheal Occlusion (FETO) can help babies with a severe condition called congenital diaphragmatic hernia (CDH).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with any surgical intervention during pregnancy such as infection, premature labor, or harm to the fetus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition involves a left-sided diaphragmatic hernia with liver displacement.
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I am pregnant, over 18, and can give consent.
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My genetic tests for chromosomes 13, 18, 21, X, and Y are normal.
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My baby has severe lung underdevelopment with an O/E LHR less than 25%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a weak cervix, with or without a stitch.
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I cannot stay at the hospital for the duration of the treatment and aftercare.
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I am positive for HIV, Hepatitis B, or Hepatitis C.
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I cannot have fetoscopic surgery due to uterine issues like fibroids.
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I have a short cervix or a condition increasing my risk of early labor.
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I have a health condition that prevents me from having surgery during pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Balloon placement operative time
Balloon removal operative time
Gestational age at delivery
+4 more
Secondary study objectives
CDH repair type
Fetal lung volume
Infant Neurodevelopment
+14 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fetal Endotracheal Occlusion (FETO)Experimental Treatment1 Intervention
Participants with severe congenital diaphragmatic hernia will undergo the FETO therapy.

Find a Location

Who is running the clinical trial?

Alireza ShamshirsazLead Sponsor
Alireza Shamshirsaz, MDPrincipal InvestigatorDirector, Maternal Fetal Care Center
1 Previous Clinical Trials
20 Total Patients Enrolled
~7 spots leftby Sep 2027
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