Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
(FETO Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Rodrigo Ruano M.D., Ph.D
Disqualifiers: Multi-fetal pregnancy, Latex allergy, Preterm labor, others
No Placebo Group
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.
12345How 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.
678910Eligibility 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.
+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.
+10 more
Trial 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
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
Rodrigo Ruano M.D., Ph.DLead Sponsor
Rodrigo RuanoLead Sponsor
References
An exchangable intra-atrial balloon device. [2017]An exchangeable atrial balloon device is described. It consists of an outer guide and a latex Foley urinary retention catheter. The guide is sutured into the atrial appendage and brought out through the chest wall. The advantages of the device are discussed.
Percutaneous transcatheter occlusion of coronary artery fistulas using detachable balloons. [2018]Three pediatric patients underwent successful transcatheter coronary artery fistula occlusion using the Debrun system. This latex balloon system offers several advantages over other occlusion systems. First, the balloon delivery and release is controlled. Second, "test occlusions" can be performed that allow simultaneous balloon inflation, coronary cineangiography, and electrocardiographic monitoring. Third, because the balloons are flow-directed, they are easily positioned in properly chosen locations. Finally, the balloons can be constructed to suit the size of the fistula. In this study, two patients received only one balloon; in the other patient two balloons were placed in the same fistula. All fistulas drained into either the right atrium or ventricle and were successfully occluded. After a follow-up period of up to 3 years, no local or systemic reactions to the balloons were recognized. We conclude that detachable balloon occlusion of coronary artery fistulas is a safe, effective alternative to surgical ligation in selected pediatric patients.
Transcatheter atrial septal defect occlusion in piglets by balloon detachable devices. [2019]Detachable balloon devices were applied in the occlusion of experimental ASDs in 20 piglets. The detachable balloons were made from Latex; the occluder balloon was placed on the left atrial side and required a floppy disk and counter-occluder(s) support from the right atrial side (17 experiments), or a second detachable balloon from the right side (3 experiments). Full occlusion was noticed in all cases. There was one device embolization in the descending aorta (device with a regular floppy disk and no counter-occluder). The device was covered by tissue in 3 to 4 weeks with the balloon flat on the septum in approximately 2 months; it required minimal rim and no wires in the left atrium. The double balloon model was wireless. The balloon detachable device was found effective and safe in the occlusion of experimental ASDs in piglets.
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]We used a safety-valve (Trans-Urethral Catheterisation Safety Valve, Class Medical, Limerick, Ireland) to prevent urethral trauma due to inflation of the anchoring balloon in the urethra during catheterisation of male spinal cord injury patients in a spinal unit. The safety-valve is attached to the balloon channel of a Foley catheter. If the balloon is inflated when it is in the urethra, the pressure valve is activated. Any fluid pushed into the balloon channel leaks out and balloon inflation stops, indicating that the balloon is not inside the bladder. The safety-valve was used in 44 catheterisations. There was leakage of water during three catheterisations. In the first case, the health professional did not inflate and deflate the balloon prior to its use. This "pre-valve inflation" step overcomes the baseline resistance pressure of the balloon and prevents fluid leaking from the valve when the catheter is in the correct position. In the second instance, the valve was found to be defective. In the third case, the catheter had been misplaced; it was removed and repositioned; there was no leakage of water during inflation of the balloon. In one out of 44 catheterisations, the catheter had been misplaced; leakage of water from the safety-valve stopped inflation of the balloon and prevented iatrogenic urethral trauma. The safety-valve may be used during catheterisation of male patients in the spinal unit to prevent urethral trauma caused by inflation of the balloon of Foley catheter in the urethra. However, health professionals should remember the few shortcomings of the catheter safety-valve.
Urethroplasty with balloon catheterization in fetal lower urinary tract obstruction: observational study of 10 fetuses. [2021]To present the preliminary outcomes of fetal urethroplasty using a coronary angioplasty balloon catheter in lower urinary tract obstruction (LUTO).
Initial experience with the new Amplatzer Duct Occluder II. [2016]Different devices are used for transcatheter occlusion of patent ductus arteriosus (PDA), each with its own limitations and complications. We report our initial single-center experience with the new Amplatzer Duct Occluder II (ADO II), which has been designed to address some of these issues.
Transcatheter embolization of congenital coronary arterial fistulas in adults. [2019]In this report, we describe our experience with transcatheter occlusion of congenital coronary arterial fistulas in adults. From November 1992 to November 1996, 5 symptomatic patients, aged from 47 to 70 years, underwent transcatheter occlusion of fistulas using a retrograde arterial approach. All had chest pain or dyspnea on exertion. Detachable balloons were used in 4 patients, and Gianturco coils in 1. Detachable balloons were implanted through a Debrun system, while the coils were implanted through a 5 French right coronary Judkins catheter. Both were passed through an 8 French guiding catheter (Amplatz II). Each patient had a single fistula. The fistulas originated from the right coronary artery in 3 patients, and from the circumflex artery in 2. They drained into the pulmonary trunk in 3 patients, into the right atrium in 1, and into a bronchial artery in the other. All fistulas were occluded completely in the catheterization laboratory, and the procedures were uncomplicated. At follow up, 3 patients underwent coronary angiography, and there was no evidence of recanalization. Transcatheter embolization in adults of single congenital coronary fistulas with detachable balloons and coils is safe and effective and can be regarded as an acceptable alternative to surgery.
Transcatheter PDA Closure Using the Gianturco-Grifka Vascular Occlusion Device. [2020]Transcatheter interventional procedures for the treatment of congenital heart defects have become increasingly important. The patent ductus arteriosus (PDA) is a common congenital defect that is amenable to transcatheter occlusion. Several transcatheter occlusion devices are available. However, due to different PDA shapes and sizes, each device cannot be used to occlude every PDA. Thus, there is a need for new safe and effective transcatheter occlusion devices. We developed a new transcatheter device, the Gianturco-Grifka Vascular Occlusion Device (GGVOD), which consists of a nylon sack attached to an end-hole catheter. A wire is advanced through the catheter into the sack. The wire coils, filling the sack, occluding the vessel, and providing transmural pressure to maintain the sack position. Prior to release, the device may be repositioned, removed, or exchanged for a different sized device. The device is available in four sizes. We evaluated this device in a canine model, occluding subclavian and carotid arteries, and surgically created aortopulmonary shunts. All vessels were occluded completely without complication. In children, we have used the device to occlude PDA and other vascular anomalies. In every patient, the PDA (or other vessel) was occluded completely and without complication. When compared with other occlusion devices, this device has several advantages: the ability to reposition the device or remove it prior to release, the ability to conform to many vascular shapes, and four different sizes. The GGVOD has become another important tool in the transcatheter armamentarium.
Coexisting left congenital diaphragmatic hernia and esophageal atresia with tracheoesophageal fistula: successful management in a premature neonate. [2019]The combination of left congenital diaphragmatic hernia (CDH) with esophageal atresia (EA) and distal tracheoesophageal fistula (TEF) is extremely rare and is considered highly lethal. The authors describe a premature neonate with this association, who is alive at 6 1/2 years of age. Temporary banding of the gastroesophageal junction and gastrostomy was performed concurrently with hernia repair and prosthetic abdominoplasty to enlarge the abdominal cavity. A right thoracotomy for ligation of the fistula, using extracorporeal membrane oxygenation (ECMO), was performed 13 days later. Complete repair of the esophageal atresia was accomplished 7 weeks after birth. The methods that have been suggested in the literature are discussed. The institution of ECMO at birth could allow a primary complete surgical repair of EA and CDH. Nevertheless, surgical management with staged repair, as described herein, can be useful.
Transcatheter occlusion of patent ductus arteriosus with a new detachable coil system (DuctOcclud): a multicenter clinical trial. [2019]A multicenter clinical trial of DuctOcclud, a new detachable coil for transcatheter occlusion of patent ductus arteriosus (PDA), was conducted. DuctOcclud was used in 35 patients (12 male and 23 female) for transcatheter occlusion of PDA between January, 1996, and April, 1997. The age of the patients ranged from 0.5 to 27.2 years (median 7.6 years) and weight from 6.3 to 70.0 kg (median 23.0 kg). The smallest diameter of PDA was 2.0+/-0.7 mm (range 1.0-3.3 mm). Pulmonary-systemic flow ratio (Qp/Qs) was 1.3+/-0.3 (range 1.0-2.2). The coils were successfully implanted in 32 (91%) patients. Of 31 patients who were followed 6 months after the procedure, 26 (84%) had no residual shunt and 5 (16%) had trivial residual shunt. One patient had infective endocarditis 1 month after the procedure but recovered completely. There were no incidences of coil embolization, hemolysis, late coil migration, or pulmonary artery stenosis. We conclude that DuctOcclud is a safe and effective device of transcatheter occlusion of PDA.