OsteoCool Tumor Ablation Post-Market Study (OPuS One)

OsteoCool Tumor Ablation Post-Market Study (OPuS One)

This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.

Study Overview

• Status: Completed
• Conditions: Metastasis Spine; Metastasis to Bone
• Intervention / Treatment: Device: OsteoCool™ RF Ablation

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada, M4N 3M5
    • Sunnybrook Health Science Centre
• France
  • Strasbourg, France
    • Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
• Germany
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig AöR
• Luxembourg
  • Luxembourg, Luxembourg, 1210
    • Centre Hospitalier de Luxembourg
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner - University Medical Center Phoenix
  • California
    • Fullerton, California, United States, 92835
      • Saint Jude Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Cumming, Georgia, United States, 30041
      • Northside Hospital
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas (UT) Southwestern Medical Center
  • Virginia
    • Woodbridge, Virginia, United States, 22193
      • Vascular Institute of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Baseline to 3 months post RF ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Baseline to 3 months post RF ablation

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2017
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): July 17, 2020

Study Registration Dates

• First Submitted: August 11, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: MDT16075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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