Trials / Recruiting
RecruitingNCT03138863
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Rodrigo Ruano · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BALT GoldbBAL2 Detachable Balloon | Latex balloon, with radio-opaque inclusion |
| DEVICE | Catheter System | 100 cm tapered micro-catheter |
Timeline
- Start date
- 2024-05-01
- Primary completion
- 2027-12-01
- Completion
- 2030-11-01
- First posted
- 2017-05-03
- Last updated
- 2026-02-23
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03138863. Inclusion in this directory is not an endorsement.