Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidioâ„¢ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obsidioâ„¢ Conformable Embolic | Device | Embolization with Obsidioâ„¢ Conformable Embolic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness endpoint | The primary effectiveness endpoint is technical success, which is defined as occlusion of the target vessel(s) after embolization with Obsidioâ„¢ Conformable Embolic as assessed via angiography or demonstration of a cast of Obsidio occluding the artery on fluoroscopy or image acquisition immediately following the index procedure. | Immediately following index procedure |
| Primary safety endpoint | The primary safety endpoint is freedom from major adverse events defined as non-target embolization events that meet serious adverse event criteria, unintended target organ or soft tissue infarction, vessel perforation/injury and catheter entrapment through 30 days of the index procedure. | 30 days following index procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who will undergo or have undergone embolization with Obsidioâ„¢ Conformable Embolic
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| Ronald Reagan UCLA Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90095 |
| United States |
| St. Joseph's Medical Center | Stockton | California | 95204 | United States |
| Christiana Hospital | Newark | Delaware | 19718 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Barnes Jewish Hosital | St Louis | Missouri | 63110 | United States |
| University Hospital | Newark | New Jersey | 07103 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27599 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Texas Houston Health Science Center | Houston | Texas | 77030 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided