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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
All subjects
  • Device: Obsidio™ Conformable Embolic
    Embolization with Obsidio™ Conformable Embolic.

Recruiting Locations

St. Joseph's Medical Center
Stockton, California 95204
Contact:
Pavan Khanna, MD
209-467-6363

Christiana Hospital
Newark, Delaware 19718
Contact:
Christopher Grilli, DO
302-733-4112

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Nariman Nezami, MD
202-444-5478

Emory University Hospital
Atlanta, Georgia 30322
Contact:
Peter Park, MD
404-712-4686

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Andrew Gordon, MD
312-695-1518

University of Kansas Hospital
Kansas City, Kansas 66160
Contact:
Aaron Rohr, MD, MS
913-588-5000

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Vincent Wu, MD
617-724-4980

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Muneeb Ahmed, MD
617-667-7000

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Kevin Henseler, MD
763-236-7601

Barnes Jewish Hosital
Saint Louis, Missouri 63110
Contact:
Alexander Ushinsky, MD
314-362-2900

University Hospital
Newark, New Jersey 07103
Contact:
Abhishek Kumar, MD
973-972-5188

Albany Medical Center
Albany, New York 12208
Contact:
Gary Siskin, MD
518-262-2397

University of North Carolina Hospital
Chapel Hill, North Carolina 27599
Contact:
Nima Kokabi, MD, FRCPC
919-843-9463

The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Ketan Shah, MD
877-632-6789

University of Texas Houston Health Science Center
Houston, Texas 77030
Contact:
Ahmed Kamel Abdel Aal, MD
713-704-4972

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Guy Johnson, MD, Pharm D
206-598-7892

More Details

NCT ID
NCT06170619
Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

Stephanie Long
763-229-4482
stephanie.long@bsci.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center