Obsidio™ Conformable Embolic Registry
- Conditions
- Hypervascular TumorsHemorrhageBleeding
- Interventions
- Device: Obsidio™ Conformable Embolic
- Registration Number
- NCT06170619
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All subjects Obsidio™ Conformable Embolic -
- Primary Outcome Measures
Name Time Method Primary effectiveness endpoint Immediately following index procedure The primary effectiveness endpoint is technical success, which is defined as occlusion of the target vessel(s) after embolization with Obsidio™ 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.
Primary safety endpoint 30 days following index procedure 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Barnes Jewish Hosital
🇺🇸Saint Louis, Missouri, United States
University Hospital
🇺🇸Newark, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University of North Carolina Hospital
🇺🇸Chapel Hill, North Carolina, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Texas Houston Health Science Center
🇺🇸Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States