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Trial record 1 of 1 for:    EU-STAR
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Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors (EU-STAR)

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ClinicalTrials.gov Identifier: NCT02081053
Recruitment Status : Terminated (Difficulty Enrolling)
First Posted : March 7, 2014
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Merit Medical Systems, Inc. ( DFINE Inc. )

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.

Condition or disease Intervention/treatment Phase
Metastatic Lesions in Vertebral Bodies Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

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




Primary Outcome Measures :
  1. Pain relief [ Time Frame: 1 month ]
    Measured by the Numerical Rating Pain Scale (NRPS)


Secondary Outcome Measures :
  1. Change in function [ Time Frame: up to 6 months ]
    Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI)

  2. Change in Quality of Life [ Time Frame: up to 6 months ]
    Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22)

  3. Change in pain medications [ Time Frame: up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081053


Locations
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France
Nouvel Höpital Civil
Strasbourg, France, 67091
Germany
Universitätsklinikum Bonn
Bonn, Germany, 53127
Goethe-Universität Frankfurt am Main
Frankfurt, Germany, 60590
Universität zu Köln
Köln, Germany, 50931
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany, 39120
Italy
Cardarelli Hospital Naples, Italy
Naples, Italy
Policlinico Tor Vergata
Rome, Italy
Ospedale di Treviso Ca' Foncello
Treviso, Italy
Sponsors and Collaborators
DFINE Inc.
Investigators
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Principal Investigator: Thomas Vogl, MD Goethe-Universität Frankfurt am Main
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Responsible Party: DFINE Inc.
ClinicalTrials.gov Identifier: NCT02081053    
Other Study ID Numbers: DF-13-03
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Keywords provided by Merit Medical Systems, Inc. ( DFINE Inc. ):
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