OsteoCool Tumor Ablation Post-Market Study (OPuS One)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03249584 |
Recruitment Status :
Completed
First Posted : August 15, 2017
Results First Posted : July 7, 2020
Last Update Posted : October 1, 2021
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Condition or disease | Intervention/treatment | Phase |
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Metastasis Spine Metastasis to Bone | Device: OsteoCool™ RF Ablation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 218 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
Official Title: | OsteoCool Tumor Ablation Post-Market Study (OPuS One) |
Actual Study Start Date : | October 12, 2017 |
Actual Primary Completion Date : | April 30, 2019 |
Actual Study Completion Date : | July 17, 2020 |
Arm | Intervention/treatment |
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OsteoCool™ RF Ablation
Subjects will undergo a single OsteoCool™ RF Ablation procedure.
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Device: 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. |
- Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation [ Time Frame: From Baseline to 3 months post 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.
- Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation [ Time Frame: From Baseline to 3 months post 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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*
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249584
United States, Arizona | |
Banner - University Medical Center Phoenix | |
Phoenix, Arizona, United States, 85006 | |
United States, California | |
Saint Jude Medical Center | |
Fullerton, California, United States, 92835 | |
United States, Florida | |
Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30322 | |
Northside Hospital | |
Cumming, Georgia, United States, 30041 | |
United States, Massachusetts | |
University of Massachusetts Memorial Medical Center | |
Worcester, Massachusetts, United States, 01655 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Nevada | |
Renown Regional Medical Center | |
Reno, Nevada, United States, 89502 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27705 | |
United States, Texas | |
University of Texas (UT) Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
United States, Virginia | |
Vascular Institute of Virginia | |
Woodbridge, Virginia, United States, 22193 | |
Canada | |
Sunnybrook Health Science Centre | |
Toronto, Canada, M4N 3M5 | |
France | |
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil | |
Strasbourg, France | |
Germany | |
Universitätsklinikum Leipzig AöR | |
Leipzig, Germany, 04103 | |
Luxembourg | |
Centre Hospitalier de Luxembourg | |
Luxembourg, Luxembourg, 1210 |
Principal Investigator: | Sandeep Bagla, MD | Vascular Institute of Virginia |
Documents provided by MedtronicNeuro:
Responsible Party: | MedtronicNeuro |
ClinicalTrials.gov Identifier: | NCT03249584 |
Other Study ID Numbers: |
MDT16075 |
First Posted: | August 15, 2017 Key Record Dates |
Results First Posted: | July 7, 2020 |
Last Update Posted: | October 1, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | Yes |
Neoplasm Metastasis Neoplastic Processes Neoplasms Pathologic Processes |