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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

NCT05962346 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-19

No results posted yet for this study

Summary

The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

DEVICE

BALT GOLDBALL 2 detachable latex ballon

Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.

DEVICE

BALTACCIBDPE100 Microcatheter

Used to deliver the detachable balloon

DEVICE

Storz fetoscopic operating sheath and miniature telescope/fetoscope

Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.

Sponsors & Collaborators

  • Mauro H. Schenone

    lead OTHER

Principal Investigators

  • Mauro Schenone, MD · Mayo Clinic

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
2026-12-31
Primary Completion
2043-07-31
Completion
2043-07-31
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 NCT05962346 on ClinicalTrials.gov