Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
125 participants
OBSERVATIONAL
2024-06-19
2025-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All subjects
Obsidio™ Conformable Embolic
Embolization with Obsidio™ Conformable Embolic.
Interventions
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Obsidio™ Conformable Embolic
Embolization with Obsidio™ Conformable Embolic.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent\*
* Patient is to undergo or has undergone embolization with Obsidio™ Conformable Embolic
* Patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits \*Patients being treated for control of bleeding/hemorrhage who are unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hours of the index procedure
Exclusion Criteria
* Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions For Use (IFU)
* Embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula)
* Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
St. Joseph's Medical Center
Stockton, California, United States
Christiana Hospital
Newark, Delaware, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Hospital
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Barnes Jewish Hosital
St Louis, Missouri, United States
University Hospital
Newark, New Jersey, United States
Albany Medical Center
Albany, New York, United States
Mount Sinai Medical Center
New York, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Houston Health Science Center
Houston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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S2513
Identifier Type: -
Identifier Source: org_study_id