OsteoCool Tumor Ablation Post-Market Study

Not Applicable

Completed

Brief Summary: This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

Detailed Description: The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and benign bone tumors such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.

Recruitment & Eligibility

Inclusion Criteria

Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
A. 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 - 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

A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)
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 subject's ability to comply with study instructions or might confound the study interpretation
- Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.

Arm && Interventions

Group	Intervention	Description
OsteoCool™ RF Ablation	OsteoCool™ RF Ablation	Subjects will undergo a single OsteoCool™ RF Ablation procedure.

Primary Outcome Measures

Name	Time	Method
Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation	From Baseline to 3 months post RF ablation	Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.

Secondary Outcome Measures

Name	Time	Method
Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation	From Baseline to 3 months post RF ablation	Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain. The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.

Locations (16): Sunnybrook Health Science Centre
🇨🇦
Toronto, Canada
Renown Regional Medical Center
🇺🇸
Reno, Nevada, United States
University of Texas (UT) Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Banner - University Medical Center Phoenix
🇺🇸
Phoenix, Arizona, United States
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Northside Hospital
🇺🇸
Cumming, Georgia, United States
Saint Jude Medical Center
🇺🇸
Fullerton, California, United States
University of Massachusetts Memorial Medical Center
🇺🇸
Worcester, Massachusetts, United States
University of North Carolina at Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Vascular Institute of Virginia
🇺🇸
Woodbridge, Virginia, United States
Universitätsklinikum Leipzig AöR
🇩🇪
Leipzig, Germany
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
🇫🇷
Strasbourg, France
Centre Hospitalier de Luxembourg
🇱🇺
Luxembourg, Luxembourg