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Device

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

N/A
Waitlist Available
Led By Rodrigo Ruano, MD, Ph.D.
Research Sponsored by Rodrigo Ruano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Isolated Left CDH with liver up
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post partum
Awards & highlights

Study Summary

This trial is testing a new procedure to see if it is safe and effective.

Who is the study for?
This trial is for pregnant individuals with a single fetus diagnosed with severe left-sided Congenital Diaphragmatic Hernia (CDH) and liver up, without other fetal anomalies or chromosomal abnormalities. The fetus must have a specific lung-to-head ratio indicating pulmonary hypoplasia, and the gestational age should be between 27 to just under 32 weeks at the time of surgery.Check my eligibility
What is being tested?
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO), using BALT GoldbBAL2 Detachable Balloon and Catheter System. This procedure aims to improve lung development in fetuses with CDH by temporarily blocking their trachea.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with any fetal surgery such as preterm labor, infection, or complications from the balloon catheter system used during FETO.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition involves the left side of my diaphragm being affected with my liver positioned higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post partum
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post partum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of unplanned balloon removal
Gestational Age at Delivery
Number of incidences of maternal complications
+3 more
Secondary outcome measures
Fetal Lung Growth as measured via Fetal Lung Volume
Fetal Lung Growth as measured via LHR
Fetal survival
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: FETO GroupExperimental Treatment2 Interventions
Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.

Find a Location

Who is running the clinical trial?

Rodrigo RuanoLead Sponsor
3 Previous Clinical Trials
29 Total Patients Enrolled
Rodrigo Ruano, MD, Ph.D.Principal InvestigatorUniversity of Miami

Media Library

BALT GoldbBAL2 Detachable Balloon (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05339152 — N/A
Congenital Diaphragmatic Hernia Research Study Groups: FETO Group
Congenital Diaphragmatic Hernia Clinical Trial 2023: BALT GoldbBAL2 Detachable Balloon Highlights & Side Effects. Trial Name: NCT05339152 — N/A
BALT GoldbBAL2 Detachable Balloon (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05339152 — N/A

Frequently Asked Questions

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

Does the current research protocol accept participants aged 30 and over?

"The age requirements for participation in this clinical trial are between 18 and 50 years old."

Answered by AI

Are there any current openings in this research project for participants?

"The details available on clinicaltrials.gov show that this particular medical trial is not presently recruiting patients, even though it has been active since 8/1/2022 and was updated most recently on 5/23/2022. However, a plethora of other trials are looking for participants at the moment."

Answered by AI

What goals is this research endeavor attempting to accomplish?

"This clinical trial, monitored over a duration of up to 34 weeks gestation, aims to assessing the Gestational Age at Delivery. Other objectives include determining the Number of days of Diaphragmatic Repair via ultrasound imaging and measuring Fetal Lung Growth by way of LHR (Lung area to head circumference Ratio). Lastly, Oxygen dependency grading will be determined for newborns according as assessed by treating physicians."

Answered by AI

Who is eligible to take part in this research investigation?

"This clinical trial is recruiting a cohort of 10 participants, aged 18 to 50 years old, affected by Morgagni hernias. Additional requirements include: single pregnancy with normal fetal karyotype; isolated left CDH with the liver elevated and severe pulmonary hypoplasia evidenced via ultrasound (LHR <25% at 180 - 296 weeks); gestational age for FETO procedure between 27-29 weeks if LHR < 25%, or 30-31 weeks if LHR is 25%-30%; psychological assessment confirming eligibility."

Answered by AI
~1 spots leftby Aug 2024