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Balloon-type Device

Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Congenital Diaphragmatic Hernia (FETO Trial)

Q: Is this research venture currently enrolling participants?

<p>This trial is presently recruiting volunteers, as indicated on clinicaltrials.gov. The first posting was made in November of 2018 and the listing was recently updated in June 2021.</p>

Q: What is the cap on the number of participants in this clinical experiment?

<p>Affirmative. The clinical trial, which was posted on November 16th 2018 has been actively recruiting participants ever since its last update on June 21st 2021. This research is seeking 10 subjects across a single site.</p>

N/A

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fetal with normal karyotype

Pregnant women age 18 years and older, who are able to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at delivery

Awards & highlights

FETO Trial Summary

This trial is testing whether a new device and surgery can help babies with a severe birth defect called Congenital Diaphragmatic Hernia.

Who is the study for?

This trial is for pregnant women over 18 with a single pregnancy and a fetus diagnosed with severe right or left Congenital Diaphragmatic Hernia (CDH), where the liver has moved up. The baby must have severely underdeveloped lungs, confirmed by ultrasound measurements, and enrollment should be before 29 weeks plus 6 days of gestation.Check my eligibility

What is being tested?

The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery on unborn babies with CDH. It involves placing a balloon in the airway to help lung growth by allowing fluid buildup. The safety and effectiveness of both the FETO procedure and its removal are being evaluated.See study design

What are the potential side effects?

Potential side effects may include complications from surgery such as preterm labor, membrane rupture, or infection. There could also be risks associated with anesthesia during the procedures.

FETO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My unborn baby has a normal chromosome analysis.

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I am a pregnant woman, 18 or older, and can give consent.

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My unborn baby has been diagnosed with a diaphragmatic hernia.

FETO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after insertion of balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age) 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

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Successful placement of Balt Goldbal2 balloon

+1 more

Secondary outcome measures

Lung Head Ratio Measurement

Lung Volume Measurement

Survival at Discharge or at 6 months if still hospitalized

FETO Trial Design

3Treatment groups

Experimental Treatment

Group I: Fetuses with R- sided CDH with O/E LHR < 45%Experimental Treatment1 Intervention

Fetuses with Right CDH (O/E LHR < 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Group II: Fetuses with Left CDH (O/E LHR < 25%)Experimental Treatment1 Intervention

Fetuses with Left CDH (O/E LHR < 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

Group III: Fetuses with L- sided CDH with O/E LHR <30%.Experimental Treatment1 Intervention

Fetuses with Left CDH (O/E LHR < 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,516 Total Patients Enrolled

Frequently Asked Questions

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

Is this research venture currently enrolling participants?

"This trial is presently recruiting volunteers, as indicated on clinicaltrials.gov. The first posting was made in November of 2018 and the listing was recently updated in June 2021."

Answered by AI

What is the cap on the number of participants in this clinical experiment?

"Affirmative. The clinical trial, which was posted on November 16th 2018 has been actively recruiting participants ever since its last update on June 21st 2021. This research is seeking 10 subjects across a single site."

Answered by AI

Recent research and studies

Journal of Pediatric SurgeryJournal

Correction of Congenital Diaphragmatic Hernia in Utero IX: Fetuses with Poor Prognosis (liver Herniation and Low Lung-to-head Ratio) Can Be Saved by Fetoscopic Temporary Tracheal Occlusion

Harrison, Michael R, George B Mychaliska, Craig T Albanese, Russell W Jennings, Jody A Farrell, Sam Hawgood, Per Sandberg, Anne H Levine, Errol Lobo, and Roy A Filly. 1998. “Correction of Congenital Diaphragmatic Hernia in Utero IX: Fetuses with Poor Prognosis (liver Herniation and Low Lung-to-head Ratio) Can Be Saved by Fetoscopic Temporary Tracheal Occlusion”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/s0022-3468(98)90524-3.

American Journal of Respiratory and Critical Care MedicineJournal

Lung Growth and Maturation After Tracheal Occlusion in Diaphragmatic Hernia

BENACHI, ALEXANDRA, BERNADETTE CHAILLEY-HEU, ANNE-LISE DELEZOIDE, MARC DOMMERGUES, FRANCIS BRUNELLE, YVES DUMEZ, and JACQUES R. BOURBON. 1998. “Lung Growth and Maturation After Tracheal Occlusion in Diaphragmatic Hernia”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/ajrccm.157.3.9611023.

New England Journal of MedicineJournal

A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia

Harrison, Michael R., Roberta L. Keller, Samuel B. Hawgood, Joseph A. Kitterman, Per L. Sandberg, Diana L. Farmer, Hanmin Lee, Roy A. Filly, Jody A. Farrell, and Craig T. Albanese. 2003. “A Randomized Trial of Fetal Endoscopic Tracheal Occlusion for Severe Fetal Congenital Diaphragmatic Hernia”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa035005.

Journal of Applied PhysiologyJournal