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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

NCT03138863 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-23

No results posted yet for this study

Summary

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

Conditions

  • Congenital Diaphragmatic Hernia
  • Pulmonary Hypoplasia
  • Pulmonary Artery Hypertension

Interventions

DEVICE

BALT GoldbBAL2 Detachable Balloon

Latex balloon, with radio-opaque inclusion

DEVICE

Catheter System

100 cm tapered micro-catheter

Sponsors & Collaborators

  • Rodrigo Ruano

    lead OTHER

Principal Investigators

  • Rodrigo Ruano, M.D., Ph.D. · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2027-12-01
Completion
2030-11-01
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 NCT03138863 on ClinicalTrials.gov