OsteoCool Tumor Ablation Post-Market Study

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

Detailed Description
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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.

Official Title
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OsteoCool Tumor Ablation Post-Market Study (OPuS One)

Conditions
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Metastasis Spine, Metastasis to Bone

Intervention / Treatment
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* Device: OsteoCool™ RF Ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Enrollment/Baseline visit, OsteoCool procedure visit and 5 post-procedure visits (3 days, 1 week, 1-, 3-, and 6-month clinic visits) and a final post-procedure study visit (12 months) for a total of 8 study related visits.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OsteoCool™ RF Ablation<br>Subjects will undergo a single OsteoCool™ RF Ablation procedure. | Device: OsteoCool™ RF Ablation<br>* The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients 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 osteomas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Worst Pain Score: Thoracic/Lumbar Spine 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. | From Baseline to 3 months post RF ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum 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. | From Baseline to 3 months post RF ablation |