Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT03138863

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Led by Rodrigo Ruano · Updated on 2026-02-23

10

Participants Needed

2

Research Sites

339 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

CONDITIONS

Official Title

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Singleton pregnancy
  • Normal fetal karyotype confirmed by culture or FISH (if >26 weeks)
  • Isolated left congenital diaphragmatic hernia with liver up
  • Gestational age before 29 weeks 6 days with severe pulmonary hypoplasia: O/E LHR <25% (measured at 18 to 29.6 weeks) or O/E LHR 25% to <30% (measured at 30 to 31.6 weeks)
  • Gestational age at FETO procedure: O/E LHR <25% at 27 to 29 weeks 6 days or O/E LHR 25% to <30% at 30 to 31 weeks 6 days
  • Meets psychosocial criteria
Not Eligible

You will not qualify if you...

  • Multi-fetal pregnancy
  • History of natural rubber latex allergy
  • Preterm labor, shortened cervix (<15 mm) or uterine anomaly predisposing to preterm labor
  • Placenta previa
  • Psychosocial ineligibility preventing consent
  • Unable to live within 30 minutes of the hospital or comply with follow-up
  • No available support person during pregnancy
  • Right-sided or bilateral CDH, or left CDH with O/E LHR ≥30%
  • Additional fetal anomalies or chromosomal abnormalities
  • Maternal contraindications to fetoscopic surgery or severe medical conditions
  • History of incompetent cervix with or without cerclage
  • Known placental abnormalities at enrollment
  • Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia
  • Maternal HIV, Hepatitis-B, or Hepatitis-C positive
  • Uterine anomalies such as large or multiple fibroids or mullerian duct abnormality
  • Participation in conflicting intervention studies or previous participation in this trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

Terminated

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Research Team

R

Rodrigo A Ruano, MD, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) | DecenTrialz