OsteoCool Tumor Ablation Post-Market Study (OPuS One)

Medtronic

Status: Completed

Conditions: Metastasis Spine; Metastasis to Bone

Treatments: Device: OsteoCool™ RF Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03249584

MDT16075

Details and patient eligibility

About

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

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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218 participants in 1 patient group

OsteoCool™ RF Ablation

Other group

Description:

Subjects will undergo a single OsteoCool™ RF Ablation procedure.

Treatment:

Device: OsteoCool™ RF Ablation