Trials / Recruiting
RecruitingNCT07187206
Safety and Efficacy of FETO in CDH Phase III
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Children's Hospital Medical Center, Cincinnati · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group
Detailed description
The purpose of this study is to demonstrate that the FETO procedure increases the neonatal survival to discharge and reduces long-term morbidity rates in fetuses found to have intrathoracic herniation of the liver with LCDH and o/e LHR \< 30% or RCDH and o/e LHR \< 45 % with intrathoracic liver herniation when compared to those that receive standard of care management that have comparable defects for side and fetal lung volumes estimates and intrathoracic liver herniation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FETO, Fetal Endoluminal Tracheal Occlusion | Fetal Endoluminal Tracheal Occlusion with Balloon placement for fetuses with congenital diaphragmatic hernia |
Timeline
- Start date
- 2025-09-30
- Primary completion
- 2032-12-01
- Completion
- 2033-03-01
- First posted
- 2025-09-22
- Last updated
- 2025-09-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07187206. Inclusion in this directory is not an endorsement.