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The STAR™ Tumor Ablation Registry

The STAR™ Tumor Ablation Registry

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02419703
Enrollment
65
Registered
2015-04-17
Start date
2015-10-31
Completion date
2017-03-20
Last updated
2017-04-12

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

Conditions

Metastatic Lesions in Vertebral Bodies

Brief summary

Registry collecting data on use of The STAR™ Tumor Ablation System.

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.

Interventions

Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.

Sponsors

DFINE Inc.
CollaboratorINDUSTRY
Merit Medical Systems, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain relief (Numerical Rating Pain Scale), post t-RFA1 monthmeasured by Numerical Rating Pain Scale (NRPS, 0-10 scale)

Secondary

MeasureTime frameDescription
Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale)1 week, 1 month, 3 month, 6 month, 12 monthmeasured by the FACT G7 & Numerical Rating Pain Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026