Study Stopped
Difficulty Enrolling
The STAR™ Tumor Ablation Registry
1 other identifier
observational
65
1 country
15
Brief Summary
Registry collecting data on use of The STAR™ Tumor Ablation System.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2015
CompletedFirst Posted
Study publicly available on registry
April 17, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2017
CompletedApril 12, 2017
April 1, 2017
1.5 years
April 10, 2015
April 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain relief (Numerical Rating Pain Scale), post t-RFA
measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)
1 month
Secondary Outcomes (1)
Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)
1 week, 1 month, 3 month, 6 month, 12 month
Study Arms (1)
Patients receiving Targeted Radiofrequency Ablation (t-RFA)
Interventions
Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.
Eligibility Criteria
Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merit Medical Systems, Inc.lead
- DFINE Inc.collaborator
Study Sites (15)
John Muir Medical Center
Concord, California, 94520, United States
Southern California Institute of Neurological Surgery
Escondido, California, 92025, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
St. Joseph's Medical Center
Stockton, California, 95204, United States
University of Colorado
Denver, Colorado, 80045, United States
Mori Bean and Brook Radiology
Jacksonville, Florida, 32216, United States
Medical Imaging & Therapeutics
Lady Lake, Florida, 32159, United States
VIR Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Tennessee
Knoxville, Tennessee, 37920, United States
Providence Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2015
First Posted
April 17, 2015
Study Start
October 1, 2015
Primary Completion
March 20, 2017
Study Completion
March 20, 2017
Last Updated
April 12, 2017
Record last verified: 2017-04