Recruiting
Phase 3

Tracheal Occlusion

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07187206

Conditions

Congenital Diaphragmatic Hernia

Pulmonary Hypoplasia

Pulmonary Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

FETO, Fetal Endoluminal Tracheal Occlusion

Study Details

Brief summary:

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Conditions

Congenital Diaphragmatic Hernia

Pulmonary Hypoplasia

Pulmonary Hypertension

Study ID

NCT07187206

Start date

Sep 30, 2025

Status verified date

Sep, 2025

Completion date

Mar 1, 2033

Anticipated

Primary completion date

Dec 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant women 18 years and older, who are able to consent
  • Singleton pregnancy
  • Gestational age at enrollment is prior to 296 weeks
  • Intrathoracic liver herniation
  • Isolated Left CDH with o/e LHR < 30% at enrollment (180 to 295 weeks) or
  • Isolated Right CDH with o/e LHR < 45% at enrollment (180 to 295 weeks)
  • Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
  • Cervical length by transvaginal ultrasound > 20 mm within 24 hours prior to FETO procedure
  • Patient meets psychosocial criteria
  • Informed consent understood

Exclusion Criteria

  • Patient < 18 years of age
  • Multi-fetal pregnancy
  • History of natural rubber latex allergy
  • Preterm labor, cervix shortened (< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa.
  • Psychosocial ineligibility, precluding consent:

  • Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial.
  • The 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 Cincinnati Children's Hospital Medical Center.
  • Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR > 45%, as determined by ultrasound.
  • No liver herniation into thoracic cavity
  • Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  • History of incompetent cervix with or without cerclage
  • Placental abnormalities (previa, abruption, accreta) 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 positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment.
  • Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure
  • 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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlu

FETO balloon placement/removal

no intervention: Fetuses with severe or moderate congenital diaphragmatic hernia will receive standard of care and op

no intervention standard of care

Interventions

FETO, Fetal Endoluminal Tracheal Occlusion

Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia

Primary outcome measure

  • Change lung growth on prenatal imaging [ Time Frame: prenatal period up to 40 weeks gestation ]

Central Contacts and Locations

Central contacts

Foong-Yen Lim, MD

(513) 636-6259Foong-Yen.Lim@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center (CCHMC)

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Foong-Yen Lim

513-803-5270foong.yen.lim@cchmc.org

Erin Watters

513-803-7024erin.watters@cchmc.org

Principal Investigator:

Foong Yen Lim

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-09-22.