Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Subjects will undergo a single OsteoCool™ RF Ablation procedure.

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.

OsteoCool™ RF Ablation

Sandeep Bagla, MD

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

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.

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.

OsteoCool Tumor Ablation Post-Market Study

OsteoCool Tumor Ablation Post-Market Study (OPuS One)

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.

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.

MedtronicNeuro

AE data are based on all available safety data (ie, based on 206 total subjects undergoing RF Ablation including 184 in only the thoracic and/or lumbar vertebral body(ies) and 22 in the periacetabulum, iliac crest, and/or sacrum).

Device, therapy, and procedure related AEs were considered reportable. Deaths due to underlying malignancy were not considered AE; all deaths were reviewed for causality by a Clinical Events Committee.

Subjects underwent a single OsteoCool™ RF Ablation procedure.

OsteoCool™ RF Ablation: 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.

Total OsteoCool™ RF Ablation

Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine.

OsteoCool™ RF Ablation in Thoracic/Lumbar Spine

Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure.

OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Canada

France

Germany

Region of Enrollment

Worst pain score (WPS) at the target treatment site in the previous 24 hours was 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.

Wost Pain Score

The baseline analysis population is based on all subjects treated with RF Ablation.

Eric Grovender

An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.

Subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies).

Spots Global Cancer Trial Database for osteocool™ rf ablation