Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Medical City Children's Hospital, Dallas, TXCongenital Diaphragmatic HerniaFetoscopic Endoluminal Tracheal Occlusion (FETO) - Device
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is testing if a new fetal therapy can help babies with a severe birth defect called Congenital Diaphragmatic Hernia (CDH) survive.

Eligible Conditions
  • Congenital Diaphragmatic Hernia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: First 28 days of postnatal life

2 weeks (prenatally)
Prenatal increase in lung volume
Week 12
Percent of neonatal survivors at time of discharge
Day 28
Mechanical Ventilator

Trial Safety

Trial Design

1 Treatment Group

Fetoscopic Endoluminal Tracheal Occlusion (FETO)
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Fetoscopic Endoluminal Tracheal Occlusion (FETO) · No Placebo Group · N/A

Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Device
Experimental Group · 1 Intervention: Fetoscopic Endoluminal Tracheal Occlusion (FETO) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: first 28 days of postnatal life

Who is running the clinical trial?

Medical City Children's HospitalLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Timothy Crombleholme, MDPrincipal InvestigatorMedical City Children's Hospital

Eligibility Criteria

Age 18+ · Female Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

How many participants have joined this experiment thus far?

"Correct. Evident from clinicaltrials.gov, this medical trial is actively looking for individuals to participate. The first posting was on September 1st 2015 and the most recent update was on February 18th 2020. 15 people are required at one site location for this study." - Anonymous Online Contributor

Unverified Answer

Are there any remaining slots available for participants in this experiment?

"Per the information posted to clinicaltrials.gov, this trial is actively enrolling participants and has been since September 1st 2015 with a most recent update on February 18th 2020." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.