DFINE is committed to building scientific evidence to support the use of our products in interventional oncology and broaden adoption of targeted RF ablation in the treatment of painful debilitating spinal metastatic disease. The STAR™ Tumor Ablation System, received FDA 510(k) clearance in 2010. After completing a STAR prospective multicenter clinical series, DFINE is now conducting two prospective clinical studies, one in the United States and one in Europe. A large STAR prospective registry is also being initiated this year to ensure prospective data collection from large numbers of patients benefiting from DFINE technology.

Moving forward the company continues to invest in clinical studies to further improve the quality of life for patients suffering from spinal diseases through innovative, minimally invasive therapies.

DFINE® sponsors ongoing clinical studies in the United States and Europe:

  • Prospective Clinical Series (PCS) | USA
  • STARRT Study | USA
  • EU STAR | Europe
  • STAR Prospective Registry | USA

pcs-study-logo

Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

 

ClinicalTrials.gov Identifier: NCT02217150

 

See Details at ClinicalTrials.gov

This study is fully enrolled

starrt-logoEvaluation of t-RFA and RF-TVA Prior to / Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) (STARRT)

The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.

 

ClinicalTrials.gov Identifier: NCT02225223

 

See Details at ClinicalTrials.gov

This study is currently recruiting participants

A Prospective, Non-randomized, Multicenter Clinical Trial to Evaluate the STAR™ Tumor Ablation System and Radiofrequency Kyphoplasty to Treat Painful Metastatic Vertebral Body Tumor(s) in the Spine

The first prospective study to focus on the substantial palliative benefits of targeted tumor ablation in the interventional oncology arena involving the spine.

 

ClinicalTrials.gov Identifier: NCT02081053

 

See Details at ClinicalTrials.gov

This study is currently recruiting participants

STAR | Registry

Patient must have a painful metastatic lesion in at least one vertebra in the thoracolumbar spine (T1-L5). Will receive t-RFA with the STAR™ Tumor Ablation System.

Site Qualifications:

  • One(1) or more procedures per month
  • Site personnel to record data, call patients, transmit data to DFINE in HIPAA compliant manner

 

ClinicalTrials.gov Identifier: NCT02419703

 

See Details at ClinicalTrials.gov

This study is currently recruiting sites