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Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

NCT06179472 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-19

No results posted yet for this study

Summary

The purpose of the study is to determine the infant survival and long-term effects of performing Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of the BALT Goldbal2 balloon at Children's Mercy Hospital. We hypothesize that FETO balloon placement may increase survival and decrease morbidity when compared to standard prenatal care for the treatment of severe left or right congenital diaphragmatic hernia (CDH).

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

DEVICE

BALT GOLDBAL2 Balloon

Placement and retrieval of the GOLDBALLOON Detachable Balloon for severe CDH

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER

  • NAFTNet FETO Consortium

    collaborator UNKNOWN

  • Inna Lobeck

    lead OTHER

Principal Investigators

  • Inna Lobeck · Physician

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-14
Primary Completion
2031-01-01
Completion
2032-01-01
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 NCT06179472 on ClinicalTrials.gov