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Cryoablation · 1 trial · 2 indications
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.
| Arm | Type | Description |
|---|---|---|
| Cryoablation | OTHER | All subjects will have cryoablation on one or two painful metastatic bone tumors. |
| Name | Type | Description |
|---|---|---|
| Cryoablation | PROCEDURE | For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator. |
Inclusion Criteria: * 18 years of age or older * Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging \[e.g. computed tomography (CT) or magnetic resonance imaging (MRI)\] with known (biopsied) primary disea...
Cryoablation is used for the palliation of painful bone metastases. It is a minimally invasive procedure that uses extreme cold to destroy cancerous tissue, thereby relieving pain associated with metastatic bone lesions. The therapy is being investigated for its safety and efficacy in this patient population.
Cryoablation is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company is conducting clinical research to evaluate the use of cryoablation for pain relief in patients with bone metastases.
Cryoablation is in Phase 1 clinical development for the palliation of painful bone metastases. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the therapy remains under clinical investigation.
Cryoablation has been studied in a completed Phase 1 clinical trial with the identifier NCT01461265, titled 'Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases.' The trial enrolled 29 participants across the United States, Canada, and France, and was not randomized or blinded.
Cryoablation works by applying extreme cold to destroy cancerous tissue, which can help alleviate pain caused by bone metastases. The procedure involves inserting a probe into the tumor to freeze and kill the abnormal cells, thereby reducing the tumor burden and associated pain.