At a glance
ClinicalIndex Comparison RecordN/ACompleted· 218 enrolled
Drug / intervention
OsteoCool™ RF Ablationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
OsteoCool Tumor Ablation Post-Market Study (OPuS One)
In Brief
A clinical study evaluating OsteoCool™ RF Ablation for Metastasis Spine and Metastasis to Bone. Completed, enrolled 218 participants across 16 sites in 5 countries.
Detailed Summary
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastasis Spine, Metastasis to Bone
CountriesCanada, France, Germany, Luxembourg, United States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartOct 2017
Primary CompletionApr 2019
Study CompletionJul 2020
TodayJul 2026
First PostedAug 15, 2017
Enrollment StartOct 12, 2017
Primary CompletionApr 30, 2019
Study CompletionJul 17, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.9 years ago
Interventions
OsteoCool™ RF Ablationdevice
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.