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Device

FETO Therapy for Diaphragmatic Hernia (FETO Trial)

N/A
Recruiting
Led By Anthony Johnson, DO
Research Sponsored by Anthony Johnson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant women age 18 years and older
Isolated Left CDH with liver up
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)
Awards & highlights

FETO Trial Summary

This trial is testing a new fetal treatment for left Congenital Diaphragmatic Hernia. If successful, it could be used in future trials with more patients.

Who is the study for?
This trial is for pregnant women over 18 with a single pregnancy and severe left Congenital Diaphragmatic Hernia (CDH) in the fetus. Eligible participants must have an LHR less than 30%, be able to stay near the hospital, and not have any conditions that risk mother or baby during surgery.Check my eligibility
What is being tested?
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy's safety and feasibility on fetuses with severe CDH. It's a preliminary study at UTHealth to see if they can join larger multi-center trials later.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with fetal surgeries such as preterm labor, complications from anesthesia, infection, or harm to the fetus.

FETO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant and 18 years or older.
Select...
My condition involves a left-sided diaphragmatic hernia with the liver positioned higher.

FETO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gestational age at delivery
Successful placement of Balt Goldbal2 balloon
Successful removal of Balt Goldbal2 balloon
Secondary outcome measures
Lung head ratio
Lung volume
Survival at 30 days
Other outcome measures
Maternal complications

FETO Trial Design

1Treatment groups
Experimental Treatment
Group I: FETO therapyExperimental Treatment1 Intervention
Intervention name: FETO therapy

Find a Location

Who is running the clinical trial?

Anthony JohnsonLead Sponsor
The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,909 Total Patients Enrolled
Anthony Johnson, DOPrincipal Investigator - The University of Texas Health Science Center, Houston
Saint Anthony Central Hospital
Medical School - Northeast Ohio Medical University
University of Texas Health Science Center, San Antonio, Residency in Otolaryngology - Head & Neck Surgery

Media Library

FETO therapy (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02596802 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: FETO therapy
Congenital Diaphragmatic Hernia Clinical Trial 2023: FETO therapy Highlights & Side Effects. Trial Name: NCT02596802 — N/A
FETO therapy (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02596802 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available in this clinical investigation?

"Yes, the data on clinicaltrials.gov specifies that this medical trial is actively in search of participants--with an initial post date of December 1st 2015 and a most recent update occurring June 29th 2022. The research calls for 20 patients at a single site."

Answered by AI

How many test subjects are currently being enrolled for this medical trial?

"Affirmative. Data from clinicaltrials.gov implies that this research, which was first announced on December 1st 2015, is recruiting participants. Approximately 20 patients are needed for the single trial site involved in this project."

Answered by AI

Who may participate in this experiment?

"This study requires 20 participants of legal age (18-45) with Morgagni hernias to abide by a set of criteria. This includes having a normal fetal karyotype, displaying severe pulmonary hypoplasia on an ultrasound as well being pregnant and singleton. Psychosocial requirements must be met in addition to providing informed consent for the clinical trial."

Answered by AI

Does this investigation accept participants over 40 years of age?

"For this trial, there are criteria that must be met to qualify for enrolment. The minimum age is 18 and the maximum age is 45 years old. Additionally, there exists a separate set of clinical trials dedicated to those under 18 as well as an additional 133 studies catering exclusively to seniors over 65."

Answered by AI
~5 spots leftby Dec 2025