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Safety and Efficacy of FETO in CDH Phase III

NCT07187206 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-22

No results posted yet for this study

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

Interventions

DEVICE

FETO, Fetal Endoluminal Tracheal Occlusion

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

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2032-12-01
Completion
2033-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187206 on ClinicalTrials.gov