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Procedure

FETO Surgery for Congenital Diaphragmatic Hernia

Q: Is enrollment in this research endeavor still available to qualified participants?

<p>From the information in clinicaltrials.gov, this medical trial is still looking for participants; it was first posted on October 2nd 2020 and its details were most recently updated on May 4th 2022.</p>

Q: How many volunteers are partaking in this research endeavor?

<p>Affirmative. According to the information located on clinicaltrials.gov, this experiment is actively recruiting participants since it was initially published on October 2nd 2020 and last updated May 4th 2022. The researchers are hoping to enroll 10 patients at a single site for their research endeavour.</p>

N/A

Recruiting

Led By Hanmin Lee, MD

Research Sponsored by Hanmin Lee

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

SEVERE pulmonary hypoplasia with US LHR O/E < 25% (measured at 180 to 295 weeks) at the time of surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after birth

Awards & highlights

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.

Who is the study for?

This trial is for pregnant women over 18 with a single pregnancy and severe left CDH in the fetus, where the liver has moved into the chest. Participants must have normal fetal chromosomes, be at 27-29 weeks gestation for surgery, meet psychosocial criteria, consent to participate, and secure payment or insurance coverage.Check my eligibility

What is being tested?

The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery on fetuses with severe lung underdevelopment due to CDH. The goal is to see if blocking the trachea prenatally can improve lung growth before birth.See study design

What are the potential side effects?

Potential side effects of FETO may include risks associated with any surgical procedure during pregnancy such as preterm labor or complications from anesthesia. Specifics are not listed but would be discussed in detail prior to consent.

Eligibility Criteria

Inclusion Criteria

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

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I am pregnant and 18 years or older.

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My unborn baby has a severe lung problem diagnosed by ultrasound.

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My condition involves the left side of my diaphragm being affected with my liver positioned higher than normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of effective placements of balloon to occlude trachea via fetoscopy

Secondary outcome measures

Determine survival rate of FETO patients

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 Design

1Treatment groups

Experimental Treatment

Group I: Device - FETOExperimental Treatment1 Intervention

Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery and removal of balloon using the BALT GOLDBAL2 balloon and BALTACCIBDPE100 catheter.

0 / 3Eligibility criteria met

Find a Location

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

Media Library

Fetoscopic Endoluminal Tracheal Occlusion (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04583644 — N/A

Congenital Diaphragmatic Hernia Research Study Groups: Device - FETO

Congenital Diaphragmatic Hernia Clinical Trial 2023: Fetoscopic Endoluminal Tracheal Occlusion Highlights & Side Effects. Trial Name: NCT04583644 — N/A

Fetoscopic Endoluminal Tracheal Occlusion (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583644 — N/A

Frequently Asked Questions

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

Is enrollment in this research endeavor still available to qualified participants?

"From the information in clinicaltrials.gov, this medical trial is still looking for participants; it was first posted on October 2nd 2020 and its details were most recently updated on May 4th 2022."

Answered by AI

How many volunteers are partaking in this research endeavor?

"Affirmative. According to the information located on clinicaltrials.gov, this experiment is actively recruiting participants since it was initially published on October 2nd 2020 and last updated May 4th 2022. The researchers are hoping to enroll 10 patients at a single site for their research endeavour."

Answered by AI

Recent research and studies

Ultrasound in Obstetrics and GynecologyJournal

Severe Diaphragmatic Hernia Treated by Fetal Endoscopic Tracheal Occlusion

Jani, J. C., K. H. Nicolaides, E. Gratacós, C. M. Valencia, E. Doné, J.-M. Martinez, L. Gucciardo, R. Cruz, and J. A. Deprest. 2009. “Severe Diaphragmatic Hernia Treated by Fetal Endoscopic Tracheal Occlusion”. Ultrasound in Obstetrics and Gynecology. Wiley. doi:10.1002/uog.6450.

American Journal of Obstetrics and GynecologyJournal

Fetal Lung-to-head Ratio in the Prediction of Survival in Severe Left-sided Diaphragmatic Hernia Treated by Fetal Endoscopic Tracheal Occlusion (FETO)

Jani, Jacques C., Kypros H. Nicolaides, Eduardo Gratacós, Hilde Vandecruys, and Jan A. Deprest. 2006. “Fetal Lung-to-head Ratio in the Prediction of Survival in Severe Left-sided Diaphragmatic Hernia Treated by Fetal Endoscopic Tracheal Occlusion (FETO)”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2006.04.004.

Journal of Pediatric SurgeryJournal

The ‘PLUG’ Odyssey: Adventures in Experimental Fetal Tracheal Occlusion

Bealer, John F, Erik D Skarsgard, Marc H Hedrick, Martin Meuli, Karen J VanderWall, Alan W Flake, N.Scott Adzick, and Michael R Harrison. 1995. “The ‘PLUG’ Odyssey: Adventures in Experimental Fetal Tracheal Occlusion”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/0022-3468(95)90590-1.

New England Journal of MedicineJournal