Trial of FETO for Severe Congenital Diaphragmatic Hernia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Aimen F. Shaaban, MD
Study ID
NCT05450653
Status
Recruiting
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Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

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

Interventions

  • FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100) — DEVICE
    A Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus with severe congenital diaphragmatic hernia (o/e LHR \<25% with liver up) during the FETO procedure between gestational age 27 weeks 0 days and 29 weeks and 6 days. The fetal tracheal balloon will be removed at between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.

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 Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's). This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant women who meet study criteria.

Key Dates

Start date
Sep 18, 2022
Status verified
Jan 2026
Primary completion
Sep 30, 2030
Completion
Nov 30, 2031

Study Design

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

Arms

  • Experimental: FETO with GOLDBAL2
    A detachable balloon will be inserted in the fetal airway during the FETO procedure.

Primary Outcome Measure

Number of successful placements of Goldballoon Detachable Balloon at gestational age 27 weeks 0 days (27w0d) to 29 weeks 6 days (29w6d) [ Time Frame: 27 weeks zero days to 29 weeks 6 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Aimen Shaaban, MD
[email protected]
312-227-4747

Find similar trials in Chicago, IL

By research site
Ann & Robert H. Lurie Children's Hospital of Chicago· Chicago, IL

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