Clinical trial NCT03249584: OsteoCool Tumor Ablation Post-Market Study
Official title: OsteoCool Tumor Ablation Post-Market Study (OPuS One)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastasis Spine
Metastasis to Bone
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
timeFrame: From Baseline to 3 months post RF ablation
Secondary outcomes:
measure: Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation
timeFrame: From Baseline to 3 months post RF ablation
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: Fullerton
country: United States
facility: Saint Jude Medical Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Cumming
country: United States
facility: Northside Hospital
state: Georgia
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: University of Texas (UT) Southwestern Medical Center
state: Texas
city: Woodbridge
country: United States
facility: Vascular Institute of Virginia
state: Virginia
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Luxembourg
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
Study officials:
affiliation: Vascular Institute of Virginia
name: Sandeep Bagla, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.