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Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe CDH

NCT07767825 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-08-17

No results posted yet for this study

Summary

The purpose of this pilot study is to evaluate the feasibility of using Fetoscopic Endoluminal Tracheal Occlusion (FETO) in 10 pregnant individuals carrying fetuses with severe congenital diaphragmatic hernia (CDH). FETO surgery will be performed at 27 weeks - 29 weeks and 6 days of gestation, and the fetoscopic removal of the balloon will be performed at 34 weeks - 34 weeks and 6 days of gestation. The primary endpoint is successful placement and removal of the balloon.

Conditions

  • Severe Congenital Diaphragmatic Hernia

Interventions

DEVICE

Goldballoon Detachable Balloon (GOLDBAL2)

GOLDBAL2 will be inserted into the fetal trachea and deployed with the Delivery Microcatheter (BALTACCI-BDPE100).

Sponsors & Collaborators

Principal Investigators

  • Jose L. Peiro, MD, PhD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-09-30
Completion
2031-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT07767825 on ClinicalTrials.gov