The STAR Prospective Clinical Series

DFINE Inc.50 enrolled

Overview

Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastasis to Vertebral Column

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The STAR™ Tumor Ablation System is indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. Exclusion Criteria: * The device is contraindicated in subjects with heart pacemakers, or other electronic device implants. * The device is contraindicated in vertebral body levels C1-7.

Locations (8)

Palomar Pomerado Health System

Escondido, California, United States

University of Southern California

Los Angeles, California, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Suburban Hospital

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Change in Pain

Mean change from baseline in worst pain score per NRPS at one month

Time frame: 1 month

Secondary Outcomes

Change in Quality of Life

Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP)

Time frame: 3 months

Change if Quality of Life

Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7)

Time frame: 3 months

Change in Function

Change from baseline at each visit using Modified Oswestry Disability Index (MODI)

Time frame: 3 months

Data from ClinicalTrials.gov

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