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OpenTrials
Completed

NCT Number: NCT02217150

The STAR 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.

Completed

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Key information

Conditions

Metastasis to Vertebral Column

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Palomar Pomerado Health System, Escondido, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Pain

    Time frame: 1 month

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

Secondary outcomes

  1. Change in Quality of Life

    Time frame: 3 months

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

  2. Change if Quality of Life

    Time frame: 3 months

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

  3. Change in Function

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

DFINE Inc.

Industry

Registry information

Official study title

The DFINE STAR™ Tumor Ablation Prospective Clinical Series

Acronym: PCS

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Aug 15, 2014
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.