OsteoCool Tumor Ablation Post-Market Study
Completed · Not applicable
Conditions studied: Metastasis Spine, Metastasis to Bone
In brief
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
Key facts
- Study ID
- NCT03249584
- Run by
- MedtronicNeuro
- People needed
- 218
- Starts
- 2017-10-12
- Expected to finish
- 2020-07-17
- Last updated by the study team
- 2021-10-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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