Recruiting

Fetoscopic Endoluminal Tracheal Occlusion

Sponsor:

Connecticut Children's Medical Center

Code:

NCT02530073

Conditions

Congenital Diaphragmatic Hernias

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Study Details

Brief summary:

The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.

Conditions

Congenital Diaphragmatic Hernias

Study ID

NCT02530073

Start date

Sep, 2015

Status verified date

Jun, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant women age 18 years and older, who are able to consent
  • Singleton pregnancy

Fetal

  • Normal Karyotype
  • Fetal Diagnosis of Isolated Left CDH with liver up
  • Gestation at enrollment prior to 29 wks plus 6 days
  • SEVERE pulmonary hypoplasia with Ultra Sound O/E LHR < 25%

Exclusion Criteria:

  • Pregnant women <18 years of age.
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  • Technical limitations precluding fetoscopic surgery
  • 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
  • Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 25%
  • Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fetoscopic Endoluminal Tracheal Occlusion (FETO)

An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio <25% (O/E LHR).

Primary outcome measure

  • Percent of neonatal survivors at time of discharge [ Time Frame: Discharge from the hospital, an expected average of 12 weeks. ]

Central Contacts and Locations

Central contacts

Katie E Boyle, MPH

860-837-6547Kboyle01@connecticutchildrens.org

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Katie E Boyle, MPH

860-837-6547Kboyle01@connecticutchildrens.org

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • congenital diaphragmatic hernia
  • FETO
  • tracheal occlusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-06-18.