Fetoscopic Endoluminal Tracheal Occlusion Surgery for Congenital Diaphragmatic Hernia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Congenital Diaphragmatic HerniaFetoscopic Endoluminal Tracheal Occlusion Surgery - Device
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing a new fetal therapy for babies with severe Congenital Diaphragmatic Hernia (CDH). The goal is to improve neonatal survival rates by increasing lung growth while the baby is still in the womb.

Eligible Conditions
  • Congenital Diaphragmatic Hernia

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6 months after birth

6 months after birth
Determine survival rate of FETO patients
Week 29
Number of effective placements of balloon to occlude trachea via fetoscopy
Week 34
Rate of fetal lung growth after FETO as measured by Lung to head circumference ratio
Rate of fetal lung growth after FETO as measured by lung volume.

Trial Safety

Trial Design

1 Treatment Group

Device - FETO
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Fetoscopic Endoluminal Tracheal Occlusion Surgery · No Placebo Group · N/A

Device - FETO
Device
Experimental Group · 1 Intervention: Fetoscopic Endoluminal Tracheal Occlusion Surgery · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after birth

Who is running the clinical trial?

Hanmin LeeLead Sponsor
Hanmin Lee, MDPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
2 Previous Clinical Trials
1 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are pregnant
Results by FISH will be acceptable if the patient is > 26 weeks
References