Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT03674372

Fetoscopic Endoluminal Tracheal Occlusion

Led by University of Colorado, Denver · Updated on 2025-06-10

10

Participants Needed

1

Research Sites

589 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fetoscopic Endoluminal Tracheal Occlusion

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women age 18 years and older, who are able to consent
  • Singleton pregnancy
  • Normal fetal karyotype
  • Fetal diagnosis of isolated left or right CDH with liver up
  • Gestation at enrollment prior to 29 weeks plus 6 days
  • Severe pulmonary hypoplasia with ultrasound left-sided O/E LHR less than 25% or right-sided O/E LHR less than 45%
Not Eligible

You will not qualify if you...

  • Pregnant women under 18 years of age
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  • Technical limitations preventing fetoscopic surgery
  • Rubber latex allergy
  • Preterm labor, shortened cervix (less than 15 mm at enrollment or within 24 hours of FETO balloon insertion), or uterine anomaly strongly predisposing to preterm labor
  • Placenta previa
  • Psychosocial ineligibility preventing consent
  • Inability to remain at FETO site during tracheal occlusion, delivery, and postnatal care

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

E

Elizabeth Torres

CONTACT

H

Halley Isberg

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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