Status:
COMPLETED
OsteoCool Tumor Ablation Post-Market Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Metastasis Spine
Metastasis to Bone
Eligibility:
All Genders
18+ years
Phase:
NA
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 collec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2020
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT03249584
Start Date
October 12 2017
End Date
July 17 2020
Last Update
October 1 2021
Active Locations (16)
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1
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
2
Saint Jude Medical Center
Fullerton, California, United States, 92835
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Emory University School of Medicine
Atlanta, Georgia, United States, 30322