Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06946576
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure — DEVICE
    FETO procedure involves insertion of a balloon into the fetal trachea under IV sedation with local anesthesia or combined spinal-epidural anesthesia. Balloon removal will take place up to 7 weeks after insertion.

Study Details

The purpose of this study is to evaluate the safety and efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in cases of severe Congenital Diaphragmatic Hernia (CDH).

Key Dates

Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fetal treatment arm
    Cases that will undergo Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure.
  • No Intervention: Expectant management arm
    Cases that meet study inclusion criteria but voluntarily decline the Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure. These cases will undergo the standard of clinical care.

Primary Outcome Measure

Outcomes of placement and removal of FETO device [ Time Frame: Device placement will take place between 27 weeks 0 days and 29 weeks 6 days gestation. Removal will take place between 34 weeks 0 days and 34 weeks 6 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239-

Find similar trials in Portland, OR

By research site
Oregon Health & Science University· Portland, OR

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