OsteoCool Tumor Ablation Post-Market Study (OPuS One)

• ClinicalTrials.gov Identifier: NCT03249584
• Recruitment Status: Active, not recruiting
• First Posted: August 15, 2017
• Results First Posted: March 25, 2020
• Last Update Posted: July 7, 2020
• Sponsor: MedtronicNeuro
• Information provided by (Responsible Party): MedtronicNeuro

Study Description

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

• 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
• Estimated Study Completion Date: October 30, 2020

Arms and Interventions

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

Primary Outcome Measures :

1. Change of Worst Pain Score: Thoracic/Lumbar 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 procedure. 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. The secondary outcome has not yet reached the planned sample size; it will be assessed once all periacetabulum, iliac crest, and/or sacrum RF Ablation subjects have reached the 3 month visit.

Eligibility Criteria

• 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

Locations

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

• 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

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT03249584
• Other Study ID Numbers: MDT16075
• First Posted: August 15, 2017
• Results First Posted: March 25, 2020
• Last Update Posted: July 7, 2020
• Last Verified: July 2020

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

Additional relevant MeSH terms:

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes