Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors

A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02081053

Acronym

EU-STAR

Enrollment

Registered

2014-03-07

Start date

2014-01-31

Completion date

2016-11-30

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

Metastatic Lesions in Vertebral Bodies

Keywords

metastatic lesions, vertebral body, ablation, targeted radio-frequency ablation, radio-frequency targeted vertebral augmentation, radiofrequency kyphoplasty, spine, vertebral augmentation, kyphoplasty, spinal ablation, pain, quality of life

Brief summary

To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.

Interventions

DEVICESTAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System

Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* One to 2 painful vertebrae (T1-L5) with evidence of osteolytic metastatic lesion with known primary histology with pathologic fracture(s) at index vertebra by MRI * Pain score ≥ 4 on the numerical rating pain scale * Life expectancy of ≥ 6 months

Exclusion criteria

* Primary tumors of the bone at index vertebra * Benign tumors of the bone at index vertebra * Osteoblastic tumors at index vertebra * Index vertebra with more than one (1) pedicle involved * Epidural extension of tumor within 5 mm of the spinal cord or without sufficient room for thermal protective maneuvers * Spinal cord compression or canal compromise requiring decompression * Radiation therapy is planned to be started on the index vertebra within 4 weeks post procedure * Radiation therapy was performed on the index vertebra within 2 months before enrollment * Major surgery of the spine was performed within 3 months before enrollment * Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty * Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra

Design outcomes

Primary

Measure	Time frame	Description
Pain relief	1 month	Measured by the Numerical Rating Pain Scale (NRPS)

Secondary

Measure	Time frame	Description
Change in function	up to 6 months	Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI)
Change in Quality of Life	up to 6 months	Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22)
Change in pain medications	up to 6 months	—

Countries

France, Germany, Italy

Outcome results

None listed

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