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Fetoscopic Endoluminal Tracheal Occlusion

NCT05771688 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-23

No results posted yet for this study

Summary

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.

Conditions

  • Hernia, DIaphragmatic, Congenital

Interventions

DEVICE

FETO therapy

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

Sponsors & Collaborators

  • Allina Health System

    collaborator OTHER

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2028-02-29
Completion
2028-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771688 on ClinicalTrials.gov