The STAR Prospective Clinical Series

Completed

• Conditions: Metastasis to Vertebral Column

• Registration Number: NCT02217150
• Lead Sponsor: DFINE Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Primary Completion: 2014-12
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Pain	1 month	Mean change from baseline in worst pain score per NRPS at one month

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	3 months	Change from baseline at each visit using Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP)
Change if Quality of Life	3 months	Change from baseline at each visit using Functional Assessment of Cancer Therapy (FACT-G7)
Change in Function	3 months	Change from baseline at each visit using Modified Oswestry Disability Index (MODI)

Trial Locations

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

Austin Radiological Associates; 🇺🇸 Austin, Texas, United States

St. Mark's Hospital; 🇺🇸 Salt Lake City, Utah, United States

Inova Alexandria Hospital; 🇺🇸 Alexandria, Virginia, United States

Providence Sacred Heart Hospital; 🇺🇸 Spokane, Washington, United States