Obsidio™ Conformable Embolic Registry

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

  • Hypervascular Tumors
  • Bleeding
  • Hemorrhage

Eligibility

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

Inclusion 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

Exclusion Criteria

  • 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

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

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

More Details

Status
Recruiting
Sponsor
Boston Scientific Corporation

Study Contact

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