Clinical trial NCT02419703: The STAR™ Tumor Ablation Registry
Official title: The STAR™ Tumor Ablation Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Lesions in Vertebral Bodies
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: DFINE Inc.
First posted: 2015-04-17
Enrollment: 65
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.

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.

Eligibility criteria: Inclusion 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.
* Have signed informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain relief (Numerical Rating Pain Scale), post t-RFA
timeFrame: 1 month
Secondary outcomes:
measure: Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)
timeFrame: 1 week, 1 month, 3 month, 6 month, 12 month
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Medical Center
state: California
city: Escondido
country: United States
facility: Southern California Institute of Neurological Surgery
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: Mori Bean and Brook Radiology
state: Florida
city: Lady Lake
country: United States
facility: Medical Imaging & Therapeutics
state: Florida
city: Chicago
country: United States
facility: VIR Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: