Obsidio™ Conformable Embolic Registry

Description

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.

Conditions

Hypervascular Tumors, Bleeding, Hemorrhage

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Study Overview

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Study Details

Study overview

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.

A Prospective, Post-Approval, Open-Label, Multi-Center United States (US) Registry to Evaluate the Effectiveness and Safety of Obsidio in Clinical Practice

Obsidio™ Conformable Embolic Registry

Condition
Hypervascular Tumors
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Hospital, Phoenix, Arizona, United States, 85054

Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States, 90095

Stockton

St. Joseph's Medical Center, Stockton, California, United States, 95204

Newark

Christiana Hospital, Newark, Delaware, United States, 19718

Washington

MedStar Georgetown University Hospital, Washington, District of Columbia, United States, 20007

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Chicago

University of Chicago Hospital, Chicago, Illinois, United States, 60637

Kansas City

University of Kansas Hospital, Kansas City, Kansas, United States, 66160

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years old
  • * Patient has the ability to comprehend and willingness to sign the informed consent form. Patients being treated for control of bleeding /hemorrhage unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hrs. of the index procedure
  • * 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 visit
  • * Patient refuses participation
  • * 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
  • * Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Scientific Corporation,

Study Record Dates

2025-06