Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2-point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Week 8 is presented.

Time frame: Baseline, Week 8

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population). The Markov chain Monte Carlo (MCMC) method of imputation was used for imputation of missing BPI-SF values with 50 imputations to be performed.

The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported average pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Baseline data and change from Baseline data is presented.

Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable average pain scores.

Analgesic (that is, opioid or non-steroidal anti-inflammatory drug \[NSAID\]) use and the reason for each change in analgesic dose was recorded at each study visit. Opioid medications were converted to a standardized MEDD. MEDD is calculated using the following formula: \[Dose\]\*\[MEDD Factor\]. MEDD Factor is based on the type and dose of the opioid received. Baseline data and change from Baseline data is presented.

Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable MEDD and NSAID data.

The Karnofsky Performance Status (KPS) scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities from Baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation. Baseline data and change from Baseline data is presented.

Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable KPS scores.

Quality of Life (QoL) as indicated by the change in overall average BPI-SF Pain Interference score from baseline to each visit was evaluated at Weeks 1, 4, 8, 12, 16, 20, and 24. Using the BPI-SF, participants rated the amount of interference from pain on a scale of 0 (does not interfere) to 10 (completely interferes) for the following areas: general activity. mood, walking ability, relations, sleep, and enjoyment. For participants with responses ≥50% of the areas at a time point, a total Pain Interference score, which was the mean of the individual area scores, was calculated programmatically at that point. Baseline data and change from Baseline data is presented.

Time frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable interference from pain scores.

The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2 point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Weeks 1, 4, 12, 16, 20, and 24 is presented.

Time frame: Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable worse pain scores.

Participants requiring additional targeted therapies to the index tumor (for example, cryoablation, radio frequency ablation \[RFA\], microwave ablation \[MWA\], high intensity focused ultrasound \[HIFU\], radiation, surgery) were withdrawn from the study. Other therapies, including pain medication and chemotherapy, were permitted during the study. All additional therapies were recorded. The number of participants requiring new therapy since the last visit is presented.

Time frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable additional pain therapy data.

The number of participants with an intra-operative non-serious adverse event, a post-operative, a non-serious adverse event, a serious adverse event, or unanticipated adverse device effects related to the cryoablation procedure is presented. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Time frame: Baseline up to 30 days post-cryoablation

Population: Participants for whom received the complete study cryoablation procedure (Safety Population).

Response was defined as a ≥2-point reduction from baseline in worst pain in last 24 hours with stable medication use (that is, no more than a 25% increase in Morphine Equivalent Daily Dose \[MEDD\] from baseline). MEDD is calculated using the following formula: \[Dose\]\*\[MEDD Factor\]. MEDD Factor is based on the type and dose of the opioid received. Pain was assessed using BPI-SF with a scale of 0 (no pain) to 10 (worst pain imaginable). Percentages are proportion of responders based on logistic regression after MCMC, multiple imputation. For visits where medication use is not available, morphine equivalent values from the most recent non-missing visit are used.

Time frame: Baseline and Week 8

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population).

Participants performed a self-assessment of OTE at Week 1 and every visit thereafter (Weeks 4, 8, 12, 16, 20 and 24). Participants were asked their opinion of the effect cryoablation procedure had on their wellbeing and asked to compare their wellbeing at the time of each follow-up visit to the previous visit or phone call. The wellbeing categories were Better than the Last Visit, The Same as the Last Visit, and Worse than the Last Visit. The percentage of participants that were reported for each wellbeing category at Weeks 1, 4, 8, 12, 16, 20, and 24 is presented.

Time frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable OTE data.