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Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)

NCT02225223 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-08-11

Study results available
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Summary

The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.

Conditions

  • Metastatic Lesions in Vertebral Bodies

Interventions

DEVICE

STAR™ Tumor Ablation System

Targeted-radiofrequency ablation (t-RFA)

DEVICE

StabiliT® Vertebral Augmentation System

Radiofrequency-targeted vertebral augmentation (RF-TVA)

Sponsors & Collaborators

  • DFINE Inc.

    collaborator INDUSTRY

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Jack Jennings, MD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225223 on ClinicalTrials.gov