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Clinical Trial 19472

Cancer Type:
Interventions:

Study Type: Supportive Care
Phase of Study: N/A
Investigators:

  • Nam Tran

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

OsteoCool Tumor Ablation Post-Market Study (OPuS One)

Summary

This study evaluates the effectiveness of the Medtronic OsteoCool¿ RF Ablation System.

Objective

5.1.1. Primary Objective(s): To demonstrate an improvement from baseline to 3 months post radiofrequency ablation in worst pain score in the past 24 hours in subjects treated for metastatic lesions in only the thoracic and/or lumbar vertebral body(ies). Worst pain score at the target treatment site will be collected from the Brief Pain Inventory (BPI). 5.1.2. Secondary Objective(s): To characterize change from baseline to 3 months post radiofrequency ablation in worst pain score in the past 24 hours in subjects treated for metastatic lesions in the periacetabulum, iliac crest, and/or sacrum, and for benign bone tumors. Worst pain score at the target treatment site will be collected from the BPI. 5.1.3. Additional Measures: To characterize change in the following measures from baseline to 3 days, 1 week, 1-, 3-, 6-, and 12- months post RF Ablation: Worst pain score at the target treatment site in the past 24 hours (excluding 3-Month visit, listed as primary and secondary endpoints) collected by the BPI. Severity of pain and impact on functioning as measured by the BPI. Health related outcomes as measured by the EuroQol-5D-5L (EQ-5D-5L). Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C15-PAL) (not applicable for subjects with benign bone tumors). Oral morphine equivalent dose (OMED). Overall response rate (subjects treated for metastatic lesions in the vertebral body only). To characterize the patient care continuum (pre and post treatment). To characterize the possible predictors of patient outcomes. To characterize change in worst pain score from baseline to post-RF ablation (prior to discharge). To characterize local tumor control of the treated site pre and post treatment images (e.g., MRI, PET, etc.) US and CAN only.

Inclusion Criteria

  • Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
  • Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors (Europe and Canada only) - no restrictions on location of lesion
  • Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
  • Localized pain resulting from no more than two sites total of metastatic disease
  • Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors)
  • Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
  • At least 18 years old at the time of informed consent

  • Exclusion Criteria

  • Implanted with heart pacemaker or other implanted electronic device
  • Use of OsteoCool in vertebral body levels C1-C7
  • Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone
  • Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection
  • Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise
  • Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression
  • Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or mixed origin are eligible for the study
  • Pregnant, breastfeeding, or plan to become pregnant during the study duration
  • Concurrent participation in another clinical study that may add additional safety risks and/or confound study results > Any condition that would interfere with the participant's ability to comply with study instructions or might confound the study interpretation