RecruitingNot ApplicableNCT05962346

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia

Sponsor

Mauro H. Schenone

Enrollment

20 participants

Start Date

Dec 1, 2026

Study Type

INTERVENTIONAL

Conditions

Congenital Diaphragmatic Hernia

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).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BALT GOLDBALL 2 detachable latex ballon, a medical device called BALTACCIBDPE100 Microcatheter, and others for people with congenital diaphragmatic hernia. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBALT GOLDBALL 2 detachable latex ballon

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

DEVICEBALTACCIBDPE100 Microcatheter

Used to deliver the detachable balloon

DEVICEStorz 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.