Recruiting

FETO Surgery

Sponsor:

University of Colorado, Denver

Code:

NCT03674372

Conditions

Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Study Details

Brief summary:

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

Congenital Diaphragmatic Hernia

Study ID

NCT03674372

Start date

Nov 16, 2018

Status verified date

Jun, 2025

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2030

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 or Right CDH with liver up
  • Gestation at enrollment prior to 29 wks plus 6 days
  • SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR < 25% or R-sided O/E LHR <45%

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
  • Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fetuses with Left CDH (O/E LHR < 25%)

Fetuses with Left CDH (O/E LHR < 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

experimental: Fetuses with L- sided CDH with O/E LHR <30%.

Fetuses with Left CDH (O/E LHR < 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

experimental: Fetuses with R- sided CDH with O/E LHR < 45%

Fetuses with Right CDH (O/E LHR < 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

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 (O/E < 25%; O/E LHR < 30 %) and right CDH (O/E LHR < 45%).

Primary outcome measure

  • Successful placement of Balt Goldbal2 balloon [ Time Frame: 7 weeks after placement ]
  • Successful removal of Balt Goldbal2 balloon [ Time Frame: Within 5 weeks prior to delivery ]
  • Gestational age at delivery [ Time Frame: At delivery ]
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age) ]

Central Contacts and Locations

Central contacts

Elizabeth Torres

720-777-1661elizabeth.torres@childrenscolorado.org

Halley Isberg

720-777-9514halley.isberg@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Elizabeth Torres

720-777-1661elizabeth.torres@childrenscolorado.org

Principal Investigator:

Sarkis Derderian, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Keywords

  • tracheal occlusion
  • FETO
  • Congenital Diaphragmatic Hernia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-06-10.