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OsteoCool Tumor Ablation Post-Market Study (OPuS One)

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
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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Brief Summary:
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

Condition or disease Intervention/treatment Phase
Metastasis Spine Metastasis to Bone Device: OsteoCool™ RF Ablation Not Applicable

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.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
OsteoCool™ RF Ablation
Subjects will undergo a single OsteoCool™ RF Ablation procedure.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region
  2. 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
  3. Report worst pain score ≥4/10 at the target treatment site within the past 24 hours
  4. Localized pain resulting from no more than two sites total of metastatic disease
  5. Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors)
  6. Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls
  7. At least 18 years old at the time of informed consent

Exclusion Criteria:

  1. A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only)
  2. Use of OsteoCool in vertebral body levels C1-C7
  3. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone
  4. Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection
  5. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise
  6. Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression
  7. 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
  8. Pregnant, breastfeeding, or plan to become pregnant during the study duration
  9. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*

  10. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Principal Investigator: Sandeep Bagla, MD Vascular Institute of Virginia
  Study Documents (Full-Text)

Documents provided by MedtronicNeuro:
Study Protocol and Statistical Analysis Plan  [PDF] January 20, 2019

More Information
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Publications of Results:

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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

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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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes