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

NCT02081053 | Terminated

• 1 other identifier: DF-13-03
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Measured by the Numerical Rating Pain Scale (NRPS)

  1 month

Secondary Outcomes (3)

• Change in function

  up to 6 months

• Change in Quality of Life

  up to 6 months

• Change in pain medications

  up to 6 months

Study Arms (1)

RF Ablation and Vertebral Augmentation

OTHER

Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System

Interventions

STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System DEVICE

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

RF Ablation and Vertebral Augmentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DFINE Inc.: lead

Study Sites (8)

Nouvel Höpital Civil

Strasbourg, 67091, France

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universität zu Köln

Cologne, 50931, Germany

Location

Goethe-Universität Frankfurt am Main

Frankfurt, 60590, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

Location

Cardarelli Hospital Naples, Italy

Naples, Italy

Location

Policlinico Tor Vergata

Rome, Italy

Location

Ospedale di Treviso Ca' Foncello

Treviso, Italy

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Vogl, MD

  Goethe-Universität Frankfurt am Main

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 7, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

IT (3); FR (1); DE (4)