Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
Part of paid clinical trials in Hartford, Connecticut.
- Sponsor
- Connecticut Children's Medical Center
- Study ID
- NCT02530073
- Status
- Recruiting
Conditions
- Congenital Diaphragmatic Hernias
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fetoscopic Endoluminal Tracheal Occlusion (FETO) — DEVICEThis study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio \<25% (O/E LHR).
Study Details
The rationale for fetal therapy in severe congenital diaphragmatic hernia (CDH) is to restore adequate lung growth for neonatal survival.
Key Dates
- Start date
- Sep 30, 2015
- Status verified
- May 2025
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2030
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Fetoscopic Endoluminal Tracheal Occlusion (FETO)An un-blinded non-randomized single arm pilot study of FETO in fetuses with congenital diaphragmatic hernia (CDH)
Primary Outcome Measure
Percent of neonatal survivors at time of discharge [ Time Frame: Discharge from the hospital, an expected average of 12 weeks. ]
Central Contacts
- Katie E Boyle, MPH860-837-6547
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 |
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