Fetoscopic Endoluminal Tracheal Occlusion

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Children's Hospitals and Clinics of Minnesota
Study ID
NCT05771688
Status
Recruiting
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Conditions

  • Hernia, DIaphragmatic, Congenital

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FETO therapy — DEVICE
    placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days

Study Details

This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.

Key Dates

Start date
Feb 22, 2024
Status verified
Feb 2024
Primary completion
Feb 29, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: FETO therapy
    FETO therapy

Primary Outcome Measure

Successful placement of Balt Goldbal2 balloon [ Time Frame: Prior to 29 weeks 6 days Gestational Age (GA) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Midwest Fetal Care CenterMinneapolisMinnesota55404
James E Fisher, MD
[email protected]
612-863-9924

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By research site
Midwest Fetal Care Center· Minneapolis, MN

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