Obsidio™ Conformable Embolic Registry

Completed

Conditions studied: Hypervascular Tumors, Bleeding, Hemorrhage

In brief

OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.

Key facts

Study ID

NCT06170619

Run by

Boston Scientific Corporation

People needed

125

Starts

2024-06-19

Expected to finish

2025-09-09

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is ≥ 18 years of age
• 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

You may not qualify if…

• Patient has a life expectancy < 30 days
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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