Spots Global Cancer Trial Database for OsteoCool Tumor Ablation Post-Market Study
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Trial Identification
Brief Title: OsteoCool Tumor Ablation Post-Market Study
Official Title: OsteoCool Tumor Ablation Post-Market Study (OPuS One)
Study ID: NCT03249584
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner - University Medical Center Phoenix, Phoenix, Arizona, United States
Saint Jude Medical Center, Fullerton, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Northside Hospital, Cumming, Georgia, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Renown Regional Medical Center, Reno, Nevada, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Texas (UT) Southwestern Medical Center, Dallas, Texas, United States
Vascular Institute of Virginia, Woodbridge, Virginia, United States
Sunnybrook Health Science Centre, Toronto, , Canada
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil, Strasbourg, , France
Universitätsklinikum Leipzig AöR, Leipzig, , Germany
Centre Hospitalier de Luxembourg, Luxembourg, , Luxembourg
Contact Details
Name: Sandeep Bagla, MD
Affiliation: Vascular Institute of Virginia
Role: PRINCIPAL_INVESTIGATOR
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