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Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender Female
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03138863
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Rodrigo Ruano
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Rodrigo Ruano, M.D., Ph.D.
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Artery Hypertension
Arms & Interventions

Arms

Experimental: FETO Group

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

Interventions

Device: - BALT GoldbBAL2 Detachable Balloon

Latex balloon, with radio-opaque inclusion

Device: - Catheter System

100 cm tapered micro-catheter

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami, Miami, Florida

Status

Address

University of Miami

Miami, Florida, 33136

Site Contact

Rodrigo Ruano, MD, Ph.D

rodrigo.ruano@miami.edu

305-689-8001

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

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