Metastatic Lesions in Vertebral Bodies Clinical Trial
— EU-STAROfficial title:
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)
Verified date | January 2017 |
Source | Merit Medical Systems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 30 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Nouvel Höpital Civil | Strasbourg | |
Germany | Universitätsklinikum Bonn | Bonn | |
Germany | Goethe-Universität Frankfurt am Main | Frankfurt | |
Germany | Universität zu Köln | Köln | |
Germany | Otto-von-Guericke-Universität Magdeburg | Magdeburg | |
Italy | Cardarelli Hospital Naples, Italy | Naples | |
Italy | Policlinico Tor Vergata | Rome | |
Italy | Ospedale di Treviso Ca' Foncello | Treviso |
Lead Sponsor | Collaborator |
---|---|
DFINE Inc. |
France, Germany, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain relief | Measured by the Numerical Rating Pain Scale (NRPS) | 1 month | |
Secondary | Change in function | Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI) | up to 6 months | |
Secondary | Change in Quality of Life | Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22) | up to 6 months | |
Secondary | Change in pain medications | up to 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02419703 -
The STARâ„¢ Tumor Ablation Registry
|
N/A | |
Terminated |
NCT02225223 -
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
|
N/A |