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Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragm Hernia

NCT02596802 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-01-24

No results posted yet for this study

Summary

The goal is to assess the feasibility and safety of implementing Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in fetuses with severe left Congenital Diaphragmatic Hernia (CDH) at UTHealth. UTHealth's success in this study (with an initial 5 patients) will determine the feasibility of UTHealth's future participation in multi-center trials of this intervention.

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

DEVICE

FETO therapy

Fetoscopic surgery at 27 to 31 weeks and 6 days gestation.

Sponsors & Collaborators

  • Anthony Johnson

    lead OTHER

Principal Investigators

  • Anthony Johnson, DO · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2024-12-20
Completion
2026-01-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02596802 on ClinicalTrials.gov