Trials / Completed
CompletedNCT03249584
OsteoCool Tumor Ablation Post-Market Study
OsteoCool Tumor Ablation Post-Market Study (OPuS One)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-10-12
- Primary completion
- 2019-04-30
- Completion
- 2020-07-17
- First posted
- 2017-08-15
- Last updated
- 2021-10-01
- Results posted
- 2020-07-07
Locations
16 sites across 5 countries: United States, Canada, France, Germany, Luxembourg
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03249584. Inclusion in this directory is not an endorsement.