The STAR™ Tumor Ablation Registry

N/ATerminatedNCT02419703

Merit Medical Systems, Inc.65 enrolled

Overview

Registry collecting data on use of The STAR™ Tumor Ablation System.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Lesions in Vertebral Bodies

Interventions

STAR™ Tumor Ablation SystemDEVICE

Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (15)

John Muir Medical Center

Concord, California, United States

Southern California Institute of Neurological Surgery

Escondido, California, United States

Outcomes

Primary Outcomes

Pain relief (Numerical Rating Pain Scale), post t-RFA

measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)

Time frame: 1 month

Secondary Outcomes

Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)

measured by the FACT G7 \& Numerical Rating Pain Scale

Time frame: 1 week, 1 month, 3 month, 6 month, 12 month

Data from ClinicalTrials.gov

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