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

Primary Purpose

Congenital Diaphragmatic Hernia

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

About this trial

This is an interventional treatment trial for Congenital Diaphragmatic Hernia focused on measuring pregnant, fetal endoscopic tracheal occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FETO with GOLDBAL2

Arm Description

A balloon will be placed in the airway of the fetus during the FETO procedure.

Outcomes

Primary Outcome Measures

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.

Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.

Number of successful retrievals of the GOLDBAL2

This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.

Secondary Outcome Measures

Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)

Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.

Change in fetal lung growth

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.

Gestational age at delivery

Survival of infant to hospital discharge or 180 days after hospitalized

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.

Number of maternal complications

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.

Full Information

NCT ID

NCT04052828

First Posted

August 8, 2019

Last Updated

October 17, 2023

Sponsor

Dr Erin Perrone

1. Study Identification

Unique Protocol Identification Number

NCT04052828

Brief Title

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

Acronym

FETO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Suspended

Why Stopped

FDA request

Study Start Date

April 5, 2021 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr Erin Perrone

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Diaphragmatic Hernia

Keywords

pregnant, fetal endoscopic tracheal occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FETO with GOLDBAL2

Arm Type

Experimental

Arm Description

A balloon will be placed in the airway of the fetus during the FETO procedure.

Intervention Type

Device

Intervention Name(s)

FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)

Intervention Description

This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.

Primary Outcome Measure Information:

Title

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.

Description

Success will be defined as completion with direct visual placement above the carina and confirmation on ultrasound done during the procedure.

Time Frame

27w0d - 29w6d

Title

Number of successful retrievals of the GOLDBAL2

Description

This will ideally occur around the 34th week of gestation and have the balloon removed prior to delivery.

Time Frame

Removal prior to delivery approximately 34 weeks of gestation

Secondary Outcome Measure Information:

Title

Change in observed to expected total fetal lung to head ratios (o/e TFLV) on prenatal magnetic resonance imaging (MRI)

Description

Fetal MRI done prior to balloon placement and again done at approximately 2 weeks of balloon retrieval.

Time Frame

baseline (prior to balloon placement), approximately 2 weeks after balloon retrieval

Title

Change in fetal lung growth

Description

Time Frame

baseline (before balloon placement), immediately prior to balloon retrieval

Title

Gestational age at delivery

Time Frame

At the time of delivery (up to approximately 34 weeks)

Title

Survival of infant to hospital discharge or 180 days after hospitalized

Description

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.

Time Frame

Discharge from hospital or up to 180 days in the hospital

Title

Number of maternal complications

Description

Time Frame

up to 4-6 weeks postpartum

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Pregnant women

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin Perrone, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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