Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia (FETO)

  • End date
    Dec 1, 2025
  • participants needed
  • sponsor
    Anthony Johnson
Updated on 4 October 2022
diaphragmatic hernia
pulmonary hypoplasia


The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention.

Condition Congenital Diaphragmatic Hernia
Treatment FETO therapy
Clinical Study IdentifierNCT02596802
SponsorAnthony Johnson
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Pregnant women age 18 years and older
Singleton pregnancy
Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
Isolated Left CDH with liver up
LHR < 25% - Gestation age at enrollment prior to 29 wks plus 6 days; O/E LHR 25- <30%
gestation age at time of enrollment prior to 31 wks plus 6 days
SEVERE pulmonary hypoplasia with US O/E LHR < 25% (measured at 18 weeks plus 0 days to
Gestational age at FETO procedure with O/E LHR < 25% at 27 weeks plus 0 days to 29 weeks plus 6 days; O/E LHR 25- <30% at FETO procedure at 30 weeks plus 0 days - 31 weeks plus 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
weeks plus 5 days) at the time of surgery; O/E LHR 25- <30% (measured at 30
Patient meets psychosocial criteria
weeks plus 0 days - 31 weeks plus 6 days) at time of surgery
Informed consent

Exclusion Criteria

Patient < 18 years of age
Multi-fetal pregnancy
History of natural rubber latex allergy
Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
Psychosocial ineligibility, precluding consent
Inability to reside within 30 minutes of The Fetal Center at Children's Memorial Hermann Hospital. and inability to comply with the travel for the follow-up requirements of the trial
Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at The Fetal Center at Children's Memorial Hermann Hospital
Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥25% (measured at
History of incompetent cervix with or without cerclage
weeks 0 days to 29 weeks 5 days) as determined by ultrasound[1]
Placental abnormalities (previa, abruption, accrete) known at time of enrollment
Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
There is no safe or technically feasible fetoscopic approach to balloon placement
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note