10 Participants Needed

Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

(FETO Trial)

Recruiting at 1 trial location
RA
Overseen ByRodrigo A Ruano, MD, Ph.D
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Rodrigo Ruano M.D., Ph.D
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the use of detachable balloons in medical procedures generally safe?

Research indicates that detachable balloons have been used safely in various medical procedures, such as occluding coronary artery fistulas in children and atrial septal defects in piglets, with no significant adverse reactions reported during follow-up periods.12345

How does the Fetal Endoscopic Tracheal Occlusion treatment differ from other treatments for congenital diaphragmatic hernia?

The Fetal Endoscopic Tracheal Occlusion (FETO) treatment is unique because it involves placing a detachable balloon in the fetus's trachea to promote lung growth before birth, which is different from traditional surgical approaches that are performed after birth. This prenatal intervention aims to improve lung development in cases of congenital diaphragmatic hernia, offering a novel approach compared to postnatal surgical repairs.678910

Research Team

RR

Rodrigo Ruano, MD, Ph.D

Principal Investigator

University of Miami

Eligibility Criteria

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 maternal health risks. The gestational age must be between 27 weeks and 31 weeks 6 days at the time of the FETO procedure, depending on specific lung-to-head ratio measurements.

Inclusion Criteria

My baby's genetic test results are normal.
You are pregnant with only one baby.
If the baby's lung size is less than 25% of what is expected at 27 to 29 weeks of pregnancy, or between 25% and 30% of what is expected at 30 to 31 weeks of pregnancy, based on the mother's last menstrual period and the first ultrasound, they will not be included.
See 3 more

Exclusion Criteria

I do not have HIV, Hepatitis-B, or Hepatitis-C.
I am at risk of early labor due to a short cervix or uterine issues.
I do not have someone to stay with me during my pregnancy at the hospital.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

FETO Procedure

Participants undergo fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system

Up to 34 weeks gestation

Delivery and Immediate Postpartum

Monitoring of maternal and fetal outcomes, including gestational age at delivery and maternal complications

Up to 41 weeks gestation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pulmonary hypertension, oxygen dependency, and other infant health outcomes

Up to 24 months post partum

Treatment Details

Interventions

  • BALT GoldbBAL2 Detachable Balloon
  • Catheter System
  • Fetal Endoscopic Tracheal Occlusion
Trial OverviewThe trial tests the safety and effectiveness of Fetoscopic Endoluminal Tracheal Occlusion (FETO), using BALT GoldbBAL2 Detachable Balloon and Catheter System to treat CDH in fetuses by occluding the trachea to promote lung growth.
Participant Groups
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.

BALT GoldbBAL2 Detachable Balloon is already approved in European Union for the following indications:

🇪🇺
Approved in European Union as BALT GoldbBAL2 Detachable Balloon for:
  • Congenital Diaphragmatic Hernia

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rodrigo Ruano M.D., Ph.D

Lead Sponsor

Trials
2
Recruited
20+

Rodrigo Ruano

Lead Sponsor

Trials
5
Recruited
40+

Findings from Research

The exchangeable atrial balloon device is designed to be implanted in the atrial appendage, providing a novel approach for potential cardiac interventions.
This device utilizes a combination of an outer guide and a latex Foley catheter, which may offer advantages in terms of accessibility and functionality during procedures involving the heart.
An exchangable intra-atrial balloon device.Chapman, LW., Mittmann, UM.[2017]
The Debrun system for transcatheter coronary artery fistula occlusion was successfully used in three pediatric patients, demonstrating controlled delivery and the ability to perform 'test occlusions' for better monitoring during the procedure.
After up to 3 years of follow-up, no adverse reactions were observed, indicating that this method is a safe and effective alternative to surgical ligation for treating coronary artery fistulas in children.
Percutaneous transcatheter occlusion of coronary artery fistulas using detachable balloons.Skimming, JW., Gessner, IH., Victorica, BE., et al.[2018]
The detachable balloon device was successfully used to fully occlude experimental atrial septal defects (ASDs) in 20 piglets, demonstrating its efficacy in this application.
The device was found to be safe, with only one instance of embolization, and it became covered by tissue within 3 to 4 weeks, indicating good integration with the heart tissue.
Transcatheter atrial septal defect occlusion in piglets by balloon detachable devices.Sideris, EB., Kaneva, A., Sideris, SE., et al.[2019]

References

An exchangable intra-atrial balloon device. [2017]
Percutaneous transcatheter occlusion of coronary artery fistulas using detachable balloons. [2018]
Transcatheter atrial septal defect occlusion in piglets by balloon detachable devices. [2019]
Possible Use of a Safety-Valve with a Foley Catheter During Catheterisation of Male Spinal Cord Injury Patients for Prevention of Urethral Trauma Caused by Inflation of the Catheter Balloon in the Urethra. [2023]
Urethroplasty with balloon catheterization in fetal lower urinary tract obstruction: observational study of 10 fetuses. [2021]
Initial experience with the new Amplatzer Duct Occluder II. [2016]
Transcatheter embolization of congenital coronary arterial fistulas in adults. [2019]
Transcatheter PDA Closure Using the Gianturco-Grifka Vascular Occlusion Device. [2020]
Coexisting left congenital diaphragmatic hernia and esophageal atresia with tracheoesophageal fistula: successful management in a premature neonate. [2019]
Transcatheter occlusion of patent ductus arteriosus with a new detachable coil system (DuctOcclud): a multicenter clinical trial. [2019]