The STAR™ Tumor Ablation Registry
- Conditions
- Metastatic Lesions in Vertebral Bodies
- Interventions
- Device: STAR™ Tumor Ablation System
- Registration Number
- NCT02419703
- Lead Sponsor
- Merit Medical Systems, Inc.
- Brief Summary
Registry collecting data on use of The STAR™ Tumor Ablation System.
- Detailed Description
The STAR Prospective Registry is an observational registry to gather clinical safety and outcome data in patients with painful spinal metastases in the thoracolumbar spine (T1-L5) following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 65
- Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.
- Have signed informed consent
- Subjects under 18 years old
- Subjects with heart pacemakers, or other electronic device implants
- Subjects intended for t-RFA in vertebral body levels C1-7
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients receiving Targeted Radiofrequency Ablation (t-RFA) STAR™ Tumor Ablation System -
- Primary Outcome Measures
Name Time Method Pain relief (Numerical Rating Pain Scale), post t-RFA 1 month measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)
- Secondary Outcome Measures
Name Time Method Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale) 1 week, 1 month, 3 month, 6 month, 12 month measured by the FACT G7 \& Numerical Rating Pain Scale
Trial Locations
- Locations (15)
Mori Bean and Brook Radiology
🇺🇸Jacksonville, Florida, United States
Medical Imaging & Therapeutics
🇺🇸Lady Lake, Florida, United States
Wake Forest Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
VIR Chicago
🇺🇸Chicago, Illinois, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
John Muir Medical Center
🇺🇸Concord, California, United States
Southern California Institute of Neurological Surgery
🇺🇸Escondido, California, United States
Providence Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado
🇺🇸Denver, Colorado, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States