Trials / Active Not Recruiting
Active Not RecruitingNCT02596802
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia
Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Anthony Johnson · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FETO therapy | Fetoscopic surgery at 27 to 31 weeks and 6 days gestation. |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2024-12-20
- Completion
- 2026-01-20
- First posted
- 2015-11-04
- Last updated
- 2025-01-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02596802. Inclusion in this directory is not an endorsement.