ClinicalTrials.gg
Sign In
TerminatedNCT02081053EU-STARUpdated Jan 20, 2017

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

An interventional study of STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System in Metastatic Lesions in Vertebral Bodies, sponsored by DFINE Inc.. Terminated at 8 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-20.

Sponsored by DFINE Inc. (part of Merit Medical Systems, Inc.) · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficulty Enrolling
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic Lesions in Vertebral Bodies

Browse trials for

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
03

In context

Pain

2,451 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

DFINE Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

First submitted before DFINE Inc. became part of Merit Medical Systems, Inc..

Browse DFINE Inc. studies →All Merit Medical Systems, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    RF Ablation and Vertebral Augmentation

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

Interventions

  • DeviceSTAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System

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

06

What researchers measure

Primary outcomes

  1. Pain relief

    Measured by the Numerical Rating Pain Scale (NRPS)

    Time frame: 1 month

Secondary outcomes

  1. Change in function

    Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI)

    Time frame: up to 6 months

  2. Change in Quality of Life

    Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22)

    Time frame: up to 6 months

  3. Change in pain medications

    Time frame: up to 6 months

07

Study locations

8 sites
  • Nouvel Höpital Civil
    Strasbourg, 67091, France
  • Universitätsklinikum Bonn
    Bonn, 53127, Germany
  • Universität zu Köln
    Cologne, 50931, Germany
  • Goethe-Universität Frankfurt am Main
    Frankfurt, 60590, Germany
  • Otto-von-Guericke-Universität Magdeburg
    Magdeburg, 39120, Germany
  • Cardarelli Hospital Naples, Italy
    Naples, Italy
  • Policlinico Tor Vergata
    Rome, Italy
  • Ospedale di Treviso Ca' Foncello
    Treviso, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02081053
Lead sponsor
DFINE Inc.
Responsible party
Sponsor
First posted
Mar 7, 2014
Start date
Jan 2014
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Jan 20, 2017

Study contacts

Thomas Vogl, MD
principal investigator · Goethe-Universität Frankfurt am Main

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pain →

Other studies from this sponsor

DFINE Inc. →

Start the discussion