The STAR Prospective Clinical Series (PCS)

The DFINE STAR™ Tumor Ablation Prospective Clinical Series

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 Overview

• Status: Completed
• Conditions: Metastasis to Vertebral Column

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92027
      • Palomar Pomerado Health System
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital
  • Texas
    • Austin, Texas, United States, 78759
      • Austin Radiological Associates
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • St. Mark's Hospital
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Inova Alexandria Hospital
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with painful spinal metastases following t-RFA with the STAR™ Tumor Ablation System.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Metastatic Lesions to the spine; Patients over the age of 18 receiving treatment using the DFINE Inc. STAR tumor ablation system for palliation of painful metastases of the spine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Mean change from baseline in worst pain score per NRPS at one month	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: DFINE Inc.
• Investigators: Principal Investigator: Sandeep Bagla, MD, Inova Alexandria Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: PCS; 20130370 (Other Identifier: WIRB)