Print

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

  • 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

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.