The STAR™ Tumor Ablation Registry

April 10, 2017 updated by: Merit Medical Systems, Inc.
Registry collecting data on use of The STAR™ Tumor Ablation System.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Concord, California, United States, 94520
        • John Muir Medical Center
      • Escondido, California, United States, 92025
        • Southern California Institute of Neurological Surgery
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
      • Stockton, California, United States, 95204
        • St. Joseph's Medical Center
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Mori Bean and Brook Radiology
      • Lady Lake, Florida, United States, 32159
        • Medical Imaging & Therapeutics
    • Illinois
      • Chicago, Illinois, United States
        • VIR Chicago
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee
    • Washington
      • Spokane, Washington, United States, 99204
        • Providence Sacred Heart Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients receiving Targeted Radiofrequency Ablation (t-RFA)
Device: STAR™ Tumor Ablation System
Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief (Numerical Rating Pain Scale), post t-RFA
Time Frame: 1 month
measured by Numerical Rating Pain Scale (NRPS, 0-10 scale)
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)
Time Frame: 1 week, 1 month, 3 month, 6 month, 12 month
measured by the FACT G7 & Numerical Rating Pain Scale
1 week, 1 month, 3 month, 6 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merit Medical Systems, Inc.

Collaborators

DFINE Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

March 20, 2017

Study Completion (ACTUAL)

March 20, 2017

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (ESTIMATE)

April 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DF-15-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Lesions in Vertebral Bodies

Clinical Trials on STAR™ Tumor Ablation System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe