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OsteoCool Tumor Ablation Post-Market Study (OPuS One)

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ClinicalTrials.gov Identifier: NCT03249584
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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
Estimated Study Completion Date : November 30, 2021

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.




Primary Outcome Measures :
  1. Improvement of worst pain score [ Time Frame: 3 months post RF ablation ]
    Demonstrate an improvement of worst pain score at the target treatment site for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected from the BPI.


Secondary Outcome Measures :
  1. Change in worst pain score [ Time Frame: 3 months post RF ablation ]
    Characterize change in worst pain score for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected from the BPI.



Information from the National Library of Medicine

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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.

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


Contacts
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Contact: Helen Berrier (US and Canada) 763-514-4000 rs.opus@medtronic.com
Contact: Isabelle Buffin (Europe) 763-514-4000 rs.opus@medtronic.com

Locations
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United States, Arizona
Banner - University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Contact: Andrea Arellano         
United States, California
Saint Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Natalie Valle         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jerry Owens         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Maria Rivas         
Northside Hospital Recruiting
Cumming, Georgia, United States, 30041
Contact: Nancy Bryant         
United States, Massachusetts
University of Massachusetts Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Mary Howk         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Shirley Jennison         
United States, Nevada
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Kimberly Olsen-Wilson         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Terry Hartman         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Magdi (Mike) Elgasim         
United States, Texas
University of Texas (UT) Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Michael Fulkerson         
United States, Virginia
Vascular Institute of Virginia Recruiting
Woodbridge, Virginia, United States, 22193
Contact: Julie Orlando         
Canada
Sunnybrook Health Science Centre Recruiting
Toronto, Canada, M4N 3M5
Contact: Harley Meirovich         
Principal Investigator: Elizabeth David         
France
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil Recruiting
Strasbourg, France
Contact: Afshin Gangi, Prof         
Germany
Universitätsklinikum Leipzig AöR Recruiting
Leipzig, Germany, 04103
Contact: Dr. Nicolas Von Der Höh         
Luxembourg
Centre Hospitalier de Luxembourg Recruiting
Luxembourg, Luxembourg, 1210
Contact: Dr. Georges Dooms         
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Principal Investigator: Sandeep Bagla, MD Vascular Institute of Virginia

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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT03249584     History of Changes
Other Study ID Numbers: MDT16075
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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