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
| Arm | Description | Assigned Intervention |
|---|---|---|
| All subjects |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Vincent Wu, MD
617-724-4980
Vincent Wu, MD
617-724-4980
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation