- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03138863
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO) (FETO)
February 29, 2024 updated by: Rodrigo Ruano
Fetal Endoscopic Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) NCT3138863
The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rodrigo A Ruano, MD, Ph.D
- Phone Number: 305.689.8001
- Email: rodrigo.ruano@miami.edu
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
Contact:
- Rodrigo Ruano, MD, Ph.D
- Phone Number: 305-689-8001
- Email: rodrigo.ruano@miami.edu
-
Principal Investigator:
- Rodrigo Ruano, M.D.
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Singleton pregnancy
- Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks.
- Isolated Left CDH with liver up
- Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) < 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to <30% (measured at 300 to 316 weeks) at time of surgery.
- Gestational age at FETO procedure with O/E LHR <25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to <30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
- Patient meets psychosocial criteria
Exclusion Criteria:
- Multi-fetal pregnancy
- History of natural rubber latex allergy
- Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Psychosocial ineligibility, precluding consent:
- Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
- Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
- Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accrete) known at time of enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
- Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FETO Group
Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.
|
Latex balloon, with radio-opaque inclusion
100 cm tapered micro-catheter
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of successfully completed FETO procedures
Time Frame: Up to 34 weeks gestation
|
The number of successful placement and removal of balloon during FETO procedure
|
Up to 34 weeks gestation
|
Operative time
Time Frame: Up to 34 weeks gestation
|
FETO placement and release operative times reported in minutes
|
Up to 34 weeks gestation
|
Frequency of unplanned balloon removal
Time Frame: Up to 34 weeks gestation
|
The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)
|
Up to 34 weeks gestation
|
Number of incidences of maternal complications
Time Frame: Up to 41 weeks gestation
|
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
|
Up to 41 weeks gestation
|
Number of participants with maternal complications
Time Frame: Up to 41 weeks gestation
|
Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
|
Up to 41 weeks gestation
|
Gestational Age at Delivery
Time Frame: Up to 41 weeks gestation
|
Gestation Age reported at time of delivery
|
Up to 41 weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal Lung Growth as measured via Fetal Lung Volume
Time Frame: Up to 41 weeks gestation
|
Fetal Lung Volume as measured via ultrasound
|
Up to 41 weeks gestation
|
Fetal Lung Growth as measured via LHR
Time Frame: Up to 41 weeks gestation
|
Lung area to head circumference Ratio (LHR) as measured via ultrasound
|
Up to 41 weeks gestation
|
Fetal survival
Time Frame: Up to 24 months post partum
|
Fetal survival reported in days
|
Up to 24 months post partum
|
Number of newborns reported at each oxygen dependency grading
Time Frame: Up to 24 months post partum
|
Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
|
Up to 24 months post partum
|
Number of occurrence of severe pulmonary hypertension
Time Frame: Up to 24 months post partum
|
Number of occurrence of severe pulmonary hypertension in infants as measured via echocardiogram
|
Up to 24 months post partum
|
Number of infants requiring ECMO Support
Time Frame: Up to 24 months post partum
|
Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support
|
Up to 24 months post partum
|
Number of days in neonatal intensive care unit
Time Frame: Up to 24 months post partum
|
Number of days infant was in the neonatal intensive care unit
|
Up to 24 months post partum
|
Number of days of ventilator support
Time Frame: Up to 24 months post partum
|
Number of reported days infants required ventilator support
|
Up to 24 months post partum
|
Number of days of maternal hospitalization
Time Frame: Up to 24 months post partum
|
Number of reported days of maternal hospitalization
|
Up to 24 months post partum
|
Number of infants reporting presence of complications
Time Frame: Up to 24 months post partum
|
Number of infants reporting the presence of: periventricular leucomalacia at < 2 months postnatally, neonatal sepsis, intraventricular hemorrhage (grade 0-III), retinopathy of prematurity (grade III or higher), gastro-esophageal reflux, tracheomegaly and tracheomalacia
|
Up to 24 months post partum
|
Number of infants requiring the use of patch or muscle flap
Time Frame: Up to 24 months post partum
|
Number of infants reported to require the use of patch or muscle flap
|
Up to 24 months post partum
|
Number of participants at each route of delivery
Time Frame: Day 1 (post partum)
|
Number of participants that delivered vaginally and via caesarean section
|
Day 1 (post partum)
|
Number of days of Diaphragmatic Repair
Time Frame: Up to 24 months post partum
|
Number of days of infant Diaphragmatic Repair
|
Up to 24 months post partum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rodrigo Ruano, M.D., Ph.D., University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
May 1, 2017
First Submitted That Met QC Criteria
May 1, 2017
First Posted (Actual)
May 3, 2017
Study Record Updates
Last Update Posted (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
February 29, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20220033-1
- 16-008720 (Other Identifier: Mayo Clinic)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Diaphragmatic Hernia
-
Timothy CrombleholmeRecruitingCongenital Diaphragmatic HerniasUnited States
-
University of California, San FranciscoNo longer availableSevere Congenital Diaphragmatic HerniaUnited States
-
University of UtahCompletedCongenital Diaphragmatic Hernia | Congenital Diaphragmatic Eventration | Congenital Hiatal Hernia | Congenital Diaphragmatic DisordersUnited States
-
Martin-Luther-Universität Halle-WittenbergUnknownSevere Congenital Diaphragmatic HerniaGermany
-
Connecticut Children's Medical CenterRecruitingCongenital Diaphragmatic HerniasUnited States
-
University Hospital, Strasbourg, FranceTerminatedCongenital Diaphragmatic HerniasFrance
-
University of Sao Paulo General HospitalMinistry of Health, BrazilUnknownCongenital Diaphragmatic Hernia | Congenital AbnormalityBrazil
-
University Hospital, LilleAPEHDia, a french CDH patient association; Rare Disease Foundation, FranceNot yet recruitingCongenital Diaphragmatic Hernia
-
University of California, DavisNot yet recruitingCongenital Diaphragmatic HerniaUnited States
-
Universitaire Ziekenhuizen KU LeuvenRecruitingCongenital Diaphragmatic HerniaBelgium
Clinical Trials on BALT GoldbBAL2 Detachable Balloon
-
Johns Hopkins UniversityRecruitingCongenital Diaphragmatic HerniaUnited States
-
University of Colorado, DenverRecruiting
-
University of Wisconsin, MadisonNot yet recruitingCongenital Diaphragmatic HerniaUnited States
-
Mauro H. SchenoneEnrolling by invitationCongenital Diaphragmatic HerniaUnited States
-
Children's Hospital of PhiladelphiaRecruitingFetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia (CHOP_FETO)Congenital Diaphragmatic Hernia | Pulmonary HypoplasiaUnited States
-
Timothy CrombleholmeRecruitingCongenital Diaphragmatic HerniasUnited States
-
Rhode Island HospitalTerminatedLung Disease | Diaphragmatic HerniaUnited States
-
Michael A BelfortBaylor College of Medicine; Universitaire Ziekenhuizen KU LeuvenCompletedCongenital Abnormalities | Hernia | Pathological Conditions, Anatomical | Hernia, Diaphragmatic | Congenital Diaphragmatic Hernia | Fetal Anomaly | Pulmonary Hypoplasia | Hernia, DIaphragmatic, Congenital | Fetal SurgeryUnited States
-
Connecticut Children's Medical CenterRecruitingCongenital Diaphragmatic HerniasUnited States
-
University of California, DavisNot yet recruitingCongenital Diaphragmatic HerniaUnited States