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Fetoscopic Endoluminal Tracheal Occlusion (FETO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674372
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO) Not Applicable

Detailed Description:

Despite advances in prenatal diagnosis and postnatal therapies, including extracorporeal membrane oxygenation (ECMO), inhaled nitric oxide therapy, and ventilator strategies that minimize ventilator-induced lung injury, morbidity and mortality rates for babies with severe CDH remain high. Data from Children's Hospital of Philadelphia (CHOP) between January 2006 and December 2010 for prenatal and postnatal care for 64 patients with isolated left CDH showed overall survival was 63%. Survival was 33% in patients requiring the use ECMO. Immediate morbidity/mortality is related to the severity of the pulmonary hypoplasia caused by the mass effect of the herniated abdominal contents on the developing lungs. Quantifying the severity of pulmonary hypoplasia has been performed using the observed/expected lung to head circumference ratio (O/E LHR). It is a tool validated in 354 fetuses with unilateral isolated CDH evaluated between 18 and 38 weeks gestation. For O/E LHR < 25%, survival was dismal at 1/9 or 11% (CHOP experience, not published). Published data from an interdisciplinary follow-up program at CHOP shows striking morbidities in neuromuscular tone and neurodevelopmental status.

The rationale for fetal therapy in severe CDH is to improve fetal lung growth and therefore neonatal survival. Prenatal tracheal occlusion obstructs the normal egress of lung fluid during pulmonary development leading to increased lung tissue stretch, increased cell proliferation, and accelerated lung growth. European colleagues have developed foregut endoscopy and techniques to position and remove endoluminal tracheal balloons in utero. Recently, the Belgium group published summary results of FETO showing an improved survival in 175 patients with isolated left CDH from 24% to 49%.

The investigators goal with this pilot study is to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E< 25%; O/E < 30%) and right CDH (O/E < 45%).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Right and Left Congenital Diaphragmatic Hernia (CDH)
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Fetuses with Left CDH (O/E LHR < 25%)
Fetuses with Left CDH (O/E LHR < 25%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E < 25%; O/E LHR < 30 %) and right CDH (O/E LHR < 45%).
Other Names:
  • BALT GOLDBALLOON: GoldBAL2 Detachable Balloon
  • BALTACCIBDPE100: Catheter System

Experimental: Fetuses with L- sided CDH with O/E LHR <30%.
Fetuses with Left CDH (O/E LHR < 30%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E < 25%; O/E LHR < 30 %) and right CDH (O/E LHR < 45%).
Other Names:
  • BALT GOLDBALLOON: GoldBAL2 Detachable Balloon
  • BALTACCIBDPE100: Catheter System

Experimental: Fetuses with R- sided CDH with O/E LHR < 45%
Fetuses with Right CDH (O/E LHR < 45%) will receive Fetoscopic Endoluminal Tracheal Occlusion (FETO)
Device: Fetoscopic Endoluminal Tracheal Occlusion (FETO)
This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E < 25%; O/E LHR < 30 %) and right CDH (O/E LHR < 45%).
Other Names:
  • BALT GOLDBALLOON: GoldBAL2 Detachable Balloon
  • BALTACCIBDPE100: Catheter System




Primary Outcome Measures :
  1. Successful placement of Balt Goldbal2 balloon [ Time Frame: 7 weeks after placement ]
    The feasibility of performing the procedure and managing the pregnancy during the period of tracheal occlusion

  2. Successful removal of Balt Goldbal2 balloon [ Time Frame: Within 5 weeks prior to delivery ]
    The feasibility of the removal of the device prior to delivery

  3. Gestational age at delivery [ Time Frame: At delivery ]
  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: After Insertion of Balloon to delivery- (from 27 weeks gestational age up to 39 weeks gestational age) ]
    Incidence of Maternal complications: preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis)


Secondary Outcome Measures :
  1. Survival at Discharge or at 6 months if still hospitalized [ Time Frame: Discharge up to 180 days post delivery ]
  2. Lung Volume Measurement [ Time Frame: 7 weeks after placement of balloon ]
  3. Lung Head Ratio Measurement [ Time Frame: 7 weeks after placement of balloon ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women age 18 years and older, who are able to consent
  • Singleton pregnancy

Fetal

  • Normal Karyotype
  • Fetal Diagnosis of Isolated Left or Right CDH with liver up
  • Gestation at enrollment prior to 29 wks plus 6 days
  • SEVERE pulmonary hypoplasia with Ultra Sound L-sided O/E LHR < 25% or R-sided O/E LHR <45%

Exclusion Criteria:

  • Pregnant women <18 years of age.
  • Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
  • Technical limitations precluding fetoscopic surgery
  • 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 remain at FETO site during time period of tracheal occlusion, delivery and postnatal care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674372


Contacts
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Contact: Hilary Hoffman 720-777-9904 hilary.hoffman@childrenscolorado.org
Contact: Halley Isberg 720-777-9514 halley.isberg@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Hilary Hoffman    720-777-9904    hilary.hoffman@childrenscolorado.org   
Principal Investigator: Kenneth Liechty, MD         
Sponsors and Collaborators
University of Colorado, Denver
Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03674372    
Other Study ID Numbers: 18-0461
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by University of Colorado, Denver:
tracheal occlusion
FETO
Congenital Diaphragmatic Hernia
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Congenital Abnormalities