The STAR Prospective Clinical Series

The DFINE STAR™ Tumor Ablation Prospective Clinical Series

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02217150

Acronym

PCS

Enrollment

Registered

2014-08-15

Start date

2013-06-30

Completion date

2016-04-30

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis to Vertebral Column

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Countries

United States

Outcome results