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ClinicalTrials.gov public records Last synced Sep 25, 2026, 5:13 PM EDT

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Showing 1–12 of 12 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Placement of the GOLDBAL2 balloon Clear all
Recruiting Not applicable Interventional

Fetal Endoscopic Tracheal Occlusion for CDH (CDH)

NCT05421676
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Device
Lead sponsor
University of California, Davis
Other
Eligibility
18 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Sacramento, California
Source: ClinicalTrials.gov public record
Updated Dec 14, 2025 · Synced Sep 25, 2026, 5:13 PM EDT
Withdrawn Not applicable Interventional

Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia

NCT06281717
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
Fetal Endotracheal Occlusion (FETO)
Device
Lead sponsor
Eyal Krispin
Other
Eligibility
18 Years and older · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 28, 2026 · Synced Sep 25, 2026, 5:13 PM EDT
Completed Not applicable Interventional

Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia

NCT00881660
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
Goldballoon Detachable Balloon and delivery microcatheter
Device
Lead sponsor
Michael A Belfort
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2023
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Nov 13, 2025 · Synced Sep 25, 2026, 5:13 PM EDT
Active, not recruiting Not applicable Interventional

Infant Survival and Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia, A Phase III Trial

NCT06179472
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
BALT GOLDBAL2 Balloon
Device
Lead sponsor
Inna Lobeck
Other
Eligibility
18 Years to 50 Years · Female only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2032
U.S. locations
1
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated Mar 18, 2026 · Synced Sep 25, 2026, 5:13 PM EDT
Completed Phase 2 Interventional Results available

'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial

NCT02875860
View directory record Official record
Conditions
Hernia, Hernia, Diaphragmatic, Hernia, DIaphragmatic, Congenital, Pathological Conditions, Anatomical, Congenital Abnormalities, Congenital Diaphragmatic Hernia, Fetal Anomaly, Fetal Surgery, Pulmonary Hypoplasia
Interventions
GoldBal2 detachable balloon, Baltaccidbpe100 Delivery Catheter, Standardized postnatal care
Device · Other
Lead sponsor
Michael A Belfort
Other
Eligibility
18 Years to 64 Years · Female only
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 22, 2022 · Synced Sep 25, 2026, 5:13 PM EDT
Recruiting Not applicable Interventional

Trial of FETO for Severe Congenital Diaphragmatic Hernia

NCT05450653
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the delivery Microcatheter (BALTACCI-BDPE100)
Device
Lead sponsor
Aimen F. Shaaban, MD
Other
Eligibility
18 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2031
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Jan 27, 2026 · Synced Sep 25, 2026, 5:13 PM EDT
Not yet recruiting Phase 3 Interventional

Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion in Congenital Diaphragmatic Hernia

NCT06946576
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
Fetoscopic Endoluminal Tracheal Occlusion (FETO) Procedure
Device
Lead sponsor
Oregon Health and Science University
Other
Eligibility
18 Years and older · Female only
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Sep 1, 2025 · Synced Sep 25, 2026, 5:13 PM EDT
Recruiting Not applicable Interventional

Fetal Endotracheal Occlusion (FETO) in the Resolution of Pulmonary Hypertension in Fetuses With Severe CDH

NCT03980717
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
Goldbal Detachable Balloon and delivery microcatheter
Device
Lead sponsor
Michael A Belfort
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2030
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 5, 2026 · Synced Sep 25, 2026, 5:13 PM EDT
Recruiting Not applicable Interventional

Safety and Efficacy of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Congenital Diaphragmatic Hernia (CDH)

NCT07577414
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Device
Lead sponsor
Dr Erin Perrone
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2038
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jun 28, 2026 · Synced Sep 25, 2026, 5:13 PM EDT
Not yet recruiting Not applicable Interventional

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Fetuses With Severe CDH

NCT07767825
View directory record Official record
Conditions
Severe Congenital Diaphragmatic Hernia
Interventions
Goldballoon Detachable Balloon (GOLDBAL2)
Device
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older · Female only
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 16, 2026 · Synced Sep 25, 2026, 5:13 PM EDT
Recruiting Not applicable Interventional

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

NCT05354505
View directory record Official record
Conditions
Diaphragmatic Hernia
Interventions
Placement of the GOLDBAL2 balloon
Device
Lead sponsor
Vincent Duron
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 28, 2026 · Synced Sep 25, 2026, 5:13 PM EDT
Completed Not applicable Interventional

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

NCT04052828
View directory record Official record
Conditions
Congenital Diaphragmatic Hernia
Interventions
FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)
Device
Lead sponsor
Dr Erin Perrone
Other
Eligibility
18 Years and older · Female only
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Jun 2, 2026 · Synced Sep 25, 2026, 5:13 PM EDT