Back to resultsOsteoCool Tumor Ablation Post-Market Study (OPuS One)
Primary Purpose
Metastasis Spine, Metastasis to Bone
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OsteoCool™ RF Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Metastasis Spine
Eligibility Criteria
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*
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.
Sites / Locations
- Banner - University Medical Center Phoenix
- Saint Jude Medical Center
- Moffitt Cancer Center
- Emory University School of Medicine
- Northside Hospital
- University of Massachusetts Memorial Medical Center
- Mayo Clinic
- Renown Regional Medical Center
- University of North Carolina at Chapel Hill
- Duke University Medical Center
- University of Texas (UT) Southwestern Medical Center
- Vascular Institute of Virginia
- Sunnybrook Health Science Centre
- Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
- Universitätsklinikum Leipzig AöR
- Centre Hospitalier de Luxembourg
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
OsteoCool™ RF Ablation
Arm Description
Subjects will undergo a single OsteoCool™ RF Ablation procedure.
Outcomes
Primary Outcome Measures
Change of Worst Pain Score: Thoracic/Lumbar Spine 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.
Secondary Outcome Measures
Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03249584
Brief Title
OsteoCool Tumor Ablation Post-Market Study
Acronym
OPuS One
Official Title
OsteoCool Tumor Ablation Post-Market Study (OPuS One)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
July 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasis Spine, Metastasis to Bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OsteoCool™ RF Ablation
Arm Type
Other
Arm Description
Subjects will undergo a single OsteoCool™ RF Ablation procedure.
Intervention Type
Device
Intervention Name(s)
OsteoCool™ RF Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
Description
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.
Time Frame
From Baseline to 3 months post RF ablation
Secondary Outcome Measure Information:
Title
Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation
Description
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.
Time Frame
From Baseline to 3 months post RF ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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*
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Bagla, MD
Organizational Affiliation
Vascular Institute of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner - University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Saint Jude Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Texas (UT) Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Vascular Institute of Virginia
City
Woodbridge
State/Province
Virginia
ZIP/Postal Code
22193
Country
United States
Facility Name
Sunnybrook Health Science Centre
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
Country
France
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Centre Hospitalier de Luxembourg
City
Luxembourg
ZIP/Postal Code
1210
Country
Luxembourg
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33129427
Citation
Levy J, Hopkins T, Morris J, Tran ND, David E, Massari F, Farid H, Vogel A, O'Connell WG, Sunenshine P, Dixon R, Gangi A, von der Hoh N, Bagla S. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol. 2020 Nov;31(11):1745-1752. doi: 10.1016/j.jvir.2020.07.014.
Results Reference
result
Learn more about this trial
OsteoCool Tumor Ablation Post-Market Study
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