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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
| All subjects |
|
Recruiting Locations
University of Kansas Hospital
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
Aaron Rohr, MD, MS
913-588-5000
Aaron Rohr, MD, MS
913-588-5000
More Details
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation