Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01461265 | Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases | PHASE1 | COMPLETED | 29 | — | — | Nov 1, 2011 | Apr 1, 2015 | Jul 16, 2021 | 4 | United States, Canada +1 |
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...