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Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH) (FETO)

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ClinicalTrials.gov Identifier: NCT04052828
Recruitment Status : Not yet recruiting
First Posted : August 12, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Erin Perrone, University of Michigan

Brief Summary:

This is a single site pilot trial to assess the feasibility and safety of treating severe CDH with Fetal Endoscopic Tracheal Occlusion with the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Michigan Medicine. The study will enroll pregnant women that meet study criteria. Participants will have placement of FETO between gestational age at 27 weeks plus 0 days and 29 weeks 6 days. The timing for removal of FETO will ideally be between 34 weeks 0 days and 34 weeks and 6 days but ultimately decided by the Fetal Diagnosis and Treatment Center at Michigan Medicine.

This study requires that study participants live within 30 miles of the Von Voigtlander Women's Hospital and C.S. Mott Children's Hospital in order to maintain weekly follow up appointments while the balloon is in place and up to delivery. Additionally, there are lifestyle considerations where participants would be unable to carry on normal daily activities including exercise and sexual intercourse, not be able to work the remainder of the pregnancy, as well as have a support person that is available to stay with such as a spouse, friend, partner, parent.


Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Device: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fetal Endoscopic Tracheal Occlusion Trial for Congenital Diaphragmatic Hernia (CDH)
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Experimental: FETO with GOLDBAL2
A balloon will be placed in the airway of the fetus during the FETO procedure.
Device: FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.




Primary Outcome Measures :
  1. Number of successful placements of the Goldballoon Detachable Balloon (GOLDBAL2) at gestational age 27 weeks zero days (27w0d) to 29 weeks and 6 days (29w6d) gestation. [ Time Frame: 27w0d - 29w6d ]
    Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.

  2. Number of successful retrievals of the GOLDBAL2 [ Time Frame: Removal prior to delivery approximately 34 weeks of gestation ]
    This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.


Secondary Outcome Measures :
  1. Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI) [ Time Frame: baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval ]
    Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.

  2. Change in fetal lung growth [ Time Frame: baseline (before balloon placement), immediately prior to balloon retrieval ]
    Fetal ultrasounds will be done weekly while the balloon is in place. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR immediately prior to balloon removal.

  3. Gestational age at delivery [ Time Frame: At the time of delivery (up to approximately 34 weeks) ]
  4. Survival of infant to hospital discharge or 180 days after hospitalized [ Time Frame: Discharge from hospital or up to 180 days in the hospital ]
    This will be measured after the infant is delivered to hospital discharge or analyzed for survival at 180 days for those still hospitalized at that time point.

  5. Number of maternal complications [ Time Frame: up to 4-6 weeks postpartum ]
    Complications during pregnancy, and/or at delivery and follow-up to include; preterm labor, premature rupture of membranes (PROM), Preterm Premature Rupture of Membranes (PPROM), oligohydramnios, polyhydramnios, placental abruption, chorioamniotic separation, chorioamnionitis, and other infection.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Singleton pregnancy
  • No pathogenic variants on microarray or pathologic findings on karyotype
  • Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects
  • Fetal CDH (left or right) with severe pulmonary hypoplasia, defined as observed-to-expected (o/e) lung to head ratios (LHR) <25% with liver up
  • Gestational age at FETO procedure: if o/e LHR <25% will be done at 27 weeks plus 0 days to 29 weeks plus 6 days
  • Meets psychosocial criteria

    • Willing to reside within 30 minutes of Von Voigtlander Women's Hospital and ability to maintain follow up appointments
    • Patient has a support person (e.g. spouse, partner, friend, parent) that is available to stay with her for the duration of the pregnancy near Von Voigtlander Women's Hospital
    • Willing to comply with restrictions of daily living including inability to exercise, have intercourse, or return to work.

Exclusion Criteria:

  • Multi-fetal pregnancy
  • History of latex allergy
  • History of preterm labor or incompetent cervix (requiring cerclage), short cervix (≤20mm), or uterine anomaly predisposing to preterm labor
  • Bilateral CDH, unilateral CDH with o/e LHR > 25%, or unilateral CDH with o/e LHR <25% but liver completely down in abdomen
  • Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
  • Maternal contraindications to elective fetoscopic surgery
  • Significant placental abnormalities (abruption, chorioangioma, accreta) known at time of enrollment and/or surgery
  • Maternal isoimmunization or neonatal alloimmune thrombocytopenia
  • Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risk of fetal transmission during the procedure
  • No safe or feasible fetoscopic approach to balloon placement
  • Social work will meet with each patient to evaluate the social situation and support system. Identifiable issues of social instability or compliance with the protocol will exclude her as a potential candidate.

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): NCT04052828


Contacts
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Contact: Erin Perrone, MD 734-936-8464 eperrone@med.umich.edu
Contact: Marjorie C Treadwell, MD 734-764-1406 mtread@med.umich.edu

Locations
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United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Erin Perrone, MD    734-936-8464    eperrone@med.umich.edu   
Contact: Marjorie C Treadwell, MD    734-764-1406    mtread@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Erin Perrone, MD University of Michigan

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Responsible Party: Dr Erin Perrone, Assistant Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT04052828     History of Changes
Other Study ID Numbers: HUM00159792
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
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: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Dr Erin Perrone, University of Michigan:
pregnant
fetal endoscopic tracheal occlusion
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Congenital Abnormalities