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

Metastatic Lesions in Vertebral Bodies Clinical Trial

— EU-STAR  

Official 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02081053
• Other study ID #: DF-13-03
• Status: Terminated
• Phase: N/A
• First received: March 4, 2014
• Last updated: January 18, 2017
• Start date: January 2014
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Metastatic Lesions in Vertebral Bodies

Intervention

Device:
• STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System
Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DFINE Inc.

Countries where clinical trial is conducted

France,  Germany,  Italy, 

Outcome

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