Obsidio™ Conformable Embolic Registry

Last updated: April 24, 2025
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Treatment

Obsidio™ Conformable Embolic

Clinical Study ID

NCT06170619
S2513
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is ≥ 18 years of age

  • Signed informed consent*

  • Patient is to undergo or has undergone embolization with Obsidio™ ConformableEmbolic

  • Patient is willing and able to comply with protocol requirements, including allprocedures, clinical evaluations, and follow-up visits *Patients being treated forcontrol 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 ofthe index procedure

Exclusion

Exclusion Criteria:

  • Patient has a life expectancy < 30 days

  • Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions ForUse (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 befed by one or more vessels

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Obsidio™ Conformable Embolic
Phase:
Study Start date:
June 19, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • St. Joseph's Medical Center

    Stockton, California 95204
    United States

    Active - Recruiting

  • Christiana Hospital

    Newark, Delaware 19718
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago Hospital

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Barnes Jewish Hosital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University Hospital

    Newark, New Jersey 07103
    United States

    Active - Recruiting

  • Albany Medical Center

    Albany, New York 12208
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Site Not Available

  • University of North Carolina Hospital

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Memorial Hermann Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Houston Health Science Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Active - Recruiting

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