Fetoscopic Endoluminal Tracheal Occlusion

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03674372
Status
Recruiting
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Conditions

  • Congenital Diaphragmatic Hernia

Eligibility Criteria

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

Interventions

  • Fetoscopic Endoluminal Tracheal Occlusion (FETO) — DEVICE
    This 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 (O/E \< 25%; O/E LHR \< 30 %) and right CDH (O/E LHR \< 45%).

Study Details

The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Key Dates

Start date
Nov 16, 2018
Status verified
Jun 2025
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

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

Arms

  • Experimental: Fetuses with Left CDH (O/E LHR < 25%)
    Fetuses with Left CDH (O/E LHR \< 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
  • Experimental: Fetuses with L- sided CDH with O/E LHR <30%.
    Fetuses with Left CDH (O/E LHR \< 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
  • Experimental: Fetuses with R- sided CDH with O/E LHR < 45%
    Fetuses with Right CDH (O/E LHR \< 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Primary Outcome Measure

Successful placement of Balt Goldbal2 balloon [ Time Frame: 7 weeks after placement ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Elizabeth Torres
[email protected]
720-777-1661
Sarkis Derderian, MD (PRINCIPAL_INVESTIGATOR)
Michael Zaretsky, MD (SUB_INVESTIGATOR)

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By research site
Children's Hospital Colorado· Aurora, CO

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