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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Lesions in Vertebral Bodies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RF Ablation and Vertebral Augmentation

Group Type OTHER

STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System

Intervention Type DEVICE

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

Interventions

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STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No