Illustration of OsteoCool radiofrequency abalation being used in the Opus One trial.

OSTEOCOOL RF ABLATION CLINICAL EVIDENCE

Learn more about the OPuS One clinical trial, a post-market study for OsteoCool™ radiofrequency ablation.
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   Indications, Safety, and Warnings

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OUTCOMES IN 100 PATIENTS TREATED WITH OSTEOCOOL™ RF ABLATION

The study demonstrates pain relief* that is:

  • Swift - 3 days post-procedure
  • Significant - improvement in worst pain
  • Sustained - through 6 months
OPUS ONE SUMMARY
OPuS One Full Publication
Chart showing a decrease in pain over the course of six months. Pain levels were rated at 8.2 out of 10 pre-ablation, and then 3.5 six months after ablation.

Study Design

The OsteoCool Post-Market Study, “OPuS One,” is a multicenter study and will include up to 250 patients in the United States, Europe, and Canada. The goal of the study is to collect real-world outcomes on effectiveness and safety among a cohort of patients who have been treated with the OsteoCool™ RF ablation system.

OsteoCool image with dual probes.

STUDY OBJECTIVES:

  • To demonstrate a reduction in worst pain score from baseline through 3 months in patients with vertebral metastases

EXPANDED COHORT ANALYSIS:

  • To characterize change in worst pain score baseline through 3 months in patients with metastatic lesions in the periacetabulum, sacrum, and iliac crest as well as benign bone tumors

MEASUREMENTS:

  • Pain
  • Function
  • Quality of life
  • Medication

POST PROCEDURE FOLLOW-UP:

  • 3 days
  • 1 week
  • 1-, 3-, 6-, and 12- months
Additional study details

MORE ON OPUS ONE

PRELIMINARY RESULTS SHOW RAPID PAIN RELIEF

Watch OPuS One Global PI, Dr. Sandeep Bagla, and site lead, Dr. Jason Levy, speak with Interventional News at SIR 2019, sharing the preliminary results and takeaways from initial patients included in the study.

PEER PERSPECTIVE ON OPUS ONE

Levy, Bagla & Tran image

Palliative care for painful bone metastases: Perspectives on OsteoCool bipolar RFA and the OPuS One Study.

Read the Interventional News advertorial
Bagla, Hopkins & Levy image

International OPuS One study to assess OsteoCool RF ablation for rapid pain palliation in patients with bony metastases.

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IMPORTANT SAFETY INFORMATION

INDICATIONS

  • Intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
  • Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy
  • Ablation of benign bone tumors such as osteoid osteoma

RISKS

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur
  • Pulmonary embolism
*

Pre-ablation worst pain was 8.2 decreasing to 5.6 (n=94) at 3 days, 4.7 (n=89) at 1 week, 3.9 (n=64) at 1 month, 3.7 (n=46) at 3 months, and 3.5 (n=22) at 6 months. P<0.0001 all visits.