Trial Outcomes & Findings for Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases (NCT NCT02511678)
NCT ID: NCT02511678
Last Updated: 2021-07-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
Baseline, Week 8
Results posted on
2021-07-19
Participant Flow
Discontinuation reasons reported below of death, withdrew consent, oncologist cancelled study cryoablation, required radiofrequency ablation, negative biopsy, protocol violation, and received radiation treatment include 7 enrolled participants who were discontinued before treatment was attempted. No other data is reported for these 7 participants.
Participant milestones
| Measure |
Cryoablation
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
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|---|---|
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Overall Study
STARTED
|
73
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
66
|
|
Overall Study
Participants Discontinued Pre-Treatment
|
7
|
|
Overall Study
Safety Population
|
65
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Cryoablation
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Death
|
19
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Targeted Therapy to Index Tumor Required
|
5
|
|
Overall Study
Oncologist Cancelled Study Cryoablation
|
1
|
|
Overall Study
Required Radiofrequency Ablation
|
1
|
|
Overall Study
Biopsy was Negative
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Received Radiation Treatment
|
1
|
Baseline Characteristics
Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
Baseline characteristics by cohort
| Measure |
Cryoablation
n=66 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
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|---|---|
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Age, Continuous
|
60.8 years
STANDARD_DEVIATION 14.3 • n=93 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
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Sex: Female, Male
Male
|
35 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: 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 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.
Outcome measures
| Measure |
Cryoablation
n=66 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
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|---|---|
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Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8
Baseline
|
7.26 score on a scale
Standard Error 0.251
|
|
Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8
Change at Week 8
|
-2.61 score on a scale
Standard Error 0.425
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 8Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT 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.
Outcome measures
| Measure |
Cryoablation
n=66 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
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|---|---|
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Percentage of Participants Who Respond to the Cryoablation Therapy
|
42.1 percentage of participants
Interval 29.9 to 55.4
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable interference from pain 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.
Outcome measures
| Measure |
Cryoablation
n=65 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
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|---|---|
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Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Baseline
|
6.6 score on a scale
Standard Deviation 2.9
|
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Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Change at Week 1
|
-1.6 score on a scale
Standard Deviation 3.8
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Change at Week 4
|
-2.2 score on a scale
Standard Deviation 3.9
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Change at Week 8
|
-2.4 score on a scale
Standard Deviation 4.0
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Change at Week 12
|
-2.9 score on a scale
Standard Deviation 3.9
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Change at Week 16
|
-3.3 score on a scale
Standard Deviation 4.0
|
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Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Change at Week 20
|
-2.7 score on a scale
Standard Deviation 4.6
|
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Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
General Activity, Change at Week 24
|
-3.4 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Baseline
|
5.1 score on a scale
Standard Deviation 2.9
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Change at Week 1
|
-1.3 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Change at Week 4
|
-2.0 score on a scale
Standard Deviation 3.7
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Change at Week 8
|
-2.4 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Change at Week 12
|
-2.7 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Change at Week 16
|
-2.7 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Change at Week 20
|
-2.4 score on a scale
Standard Deviation 3.9
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Mood, Change at Week 24
|
-2.6 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Baseline
|
5.7 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Change at Week 1
|
-1.7 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Change at Week 4
|
-1.8 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Change at Week 8
|
-1.4 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Change at Week 12
|
-1.9 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Change at Week 16
|
-2.5 score on a scale
Standard Deviation 3.3
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Change at Week 20
|
-2.3 score on a scale
Standard Deviation 3.51
|
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Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Walking Ability, Change at Week 24
|
-2.3 score on a scale
Standard Deviation 2.9
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Work, Baseline
|
6.4 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Work, Change at Week 1
|
-1.2 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Work, Change at Week 4
|
-2.6 score on a scale
Standard Deviation 4.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Work, Change at Week 8
|
-2.1 score on a scale
Standard Deviation 4.0
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Work, Change at Week 12
|
-2.5 score on a scale
Standard Deviation 4.6
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Work, Change at Week 16
|
-3.2 score on a scale
Standard Deviation 4.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Week, Change at Week 20
|
-2.5 score on a scale
Standard Deviation 4.6
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Normal Week, Change at Week 24
|
-3.0 score on a scale
Standard Deviation 3.7
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Baseline
|
4.0 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Change at Week 1
|
-1.8 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Change at Week 4
|
-1.7 score on a scale
Standard Deviation 3.7
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Change at Week 8
|
-1.5 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Change at Week 12
|
-2.2 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Change at Week 16
|
-2.4 score on a scale
Standard Deviation 3.3
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Change at Week 20
|
-2.5 score on a scale
Standard Deviation 3.8
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Relations, Change at Week 24
|
-2.4 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Baseline
|
5.8 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Change at Week 1
|
-2.2 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Change at Week 4
|
-2.5 score on a scale
Standard Deviation 3.8
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Change at Week 8
|
-2.3 score on a scale
Standard Deviation 3.3
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Change at Week 12
|
-3.1 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Change at Week 16
|
-4.1 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Change at Week 20
|
-2.5 score on a scale
Standard Deviation 3.9
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Sleep, Change at Week 24
|
-3.0 score on a scale
Standard Deviation 3.9
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Baseline
|
5.4 score on a scale
Standard Deviation 3.6
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Change at Week 1
|
-1.9 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Change at Week 4
|
-2.5 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Change at Week 8
|
-2.2 score on a scale
Standard Deviation 3.4
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Change at Week 12
|
-2.8 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Change at Week 16
|
-3.4 score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Change at Week 20
|
-2.6 score on a scale
Standard Deviation 4.3
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Enjoyment, Change at Week 24
|
-3.3 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Baseline
|
5.5 score on a scale
Standard Deviation 2.5
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Change at Week 1
|
-1.7 score on a scale
Standard Deviation 2.6
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Change at Week 4
|
-2.2 score on a scale
Standard Deviation 3.1
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Change at Week 8
|
-2.0 score on a scale
Standard Deviation 2.8
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Change at Week 12
|
-2.6 score on a scale
Standard Deviation 2.8
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Change at Week 16
|
-3.1 score on a scale
Standard Deviation 2.8
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Change at Week 20
|
-2.5 score on a scale
Standard Deviation 3.2
|
|
Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.
Total Pain, Change at Week 24
|
-2.9 score on a scale
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable KPS scores.
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.
Outcome measures
| Measure |
Cryoablation
n=66 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
|
|---|---|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Baseline
|
80.6 units on a scale
Standard Deviation 14.5
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 1
|
-5.0 units on a scale
Standard Deviation 10.8
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 4
|
-4.5 units on a scale
Standard Deviation 11.4
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 8
|
-7.3 units on a scale
Standard Deviation 15.7
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 12
|
-5.4 units on a scale
Standard Deviation 14.3
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 16
|
-3.6 units on a scale
Standard Deviation 14.1
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 20
|
-7.0 units on a scale
Standard Deviation 16.0
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 24
|
-7.5 units on a scale
Standard Deviation 18.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable additional pain therapy data.
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.
Outcome measures
| Measure |
Cryoablation
n=66 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
|
|---|---|
|
Number of Participants With Additional Pain Therapies
Week 1
|
17 Participants
|
|
Number of Participants With Additional Pain Therapies
Week 4
|
30 Participants
|
|
Number of Participants With Additional Pain Therapies
Week 8
|
29 Participants
|
|
Number of Participants With Additional Pain Therapies
Week 12
|
24 Participants
|
|
Number of Participants With Additional Pain Therapies
Week 16
|
25 Participants
|
|
Number of Participants With Additional Pain Therapies
Week 20
|
21 Participants
|
|
Number of Participants With Additional Pain Therapies
Week 24
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable MEDD and NSAID data.
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.
Outcome measures
| Measure |
Cryoablation
n=66 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
|
|---|---|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Baseline
|
31.365 milligrams (mg)
Standard Deviation 69.9231
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Change at Week 1
|
4.123 milligrams (mg)
Standard Deviation 44.0061
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Change at Week 4
|
5.884 milligrams (mg)
Standard Deviation 55.6215
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Change at Week 8
|
-0.466 milligrams (mg)
Standard Deviation 37.1101
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Change at Week 12
|
2.019 milligrams (mg)
Standard Deviation 41.4507
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Change at Week 16
|
7.404 milligrams (mg)
Standard Deviation 20.9301
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Change at Week 20
|
8.927 milligrams (mg)
Standard Deviation 20.2095
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
MEDD, Change at Week 24
|
4.392 milligrams (mg)
Standard Deviation 15.0878
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Baseline
|
60.8 milligrams (mg)
Standard Deviation 251.32
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Change at Week 1
|
4.1 milligrams (mg)
Standard Deviation 126.15
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Change at Week 4
|
-6.1 milligrams (mg)
Standard Deviation 278.40
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Change at Week 8
|
-6.1 milligrams (mg)
Standard Deviation 371.14
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Change at Week 12
|
-32.9 milligrams (mg)
Standard Deviation 401.50
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Change at Week 16
|
-53.8 milligrams (mg)
Standard Deviation 342.47
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Change at Week 20
|
-55.4 milligrams (mg)
Standard Deviation 304.09
|
|
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
NSAID, Change at Week 24
|
-68.9 milligrams (mg)
Standard Deviation 312.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable worse 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.
Outcome measures
| Measure |
Cryoablation
n=66 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
|
|---|---|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Baseline
|
7.3 score on a scale
Standard Deviation 2.04
|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Change at Week 1
|
-2.0 score on a scale
Standard Deviation 2.6
|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Change at Week 4
|
-2.6 score on a scale
Standard Deviation 3.12
|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Change at Week 8
|
-2.5 score on a scale
Standard Deviation 3.23
|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Change at Week 12
|
-3.3 score on a scale
Standard Deviation 3.53
|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Change at Week 16
|
-3.6 score on a scale
Standard Deviation 3.46
|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Change at Week 20
|
-3.5 score on a scale
Standard Deviation 3.32
|
|
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Change at Week 24
|
-3.4 score on a scale
Standard Deviation 3.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable average pain scores.
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.
Outcome measures
| Measure |
Cryoablation
n=65 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
|
|---|---|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Baseline
|
5.6 score on a scale
Standard Deviation 1.93
|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 1
|
-1.6 score on a scale
Standard Deviation 2.49
|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 4
|
-2.1 score on a scale
Standard Deviation 2.65
|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 8
|
-1.8 score on a scale
Standard Deviation 2.66
|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 12
|
-2.6 score on a scale
Standard Deviation 2.5
|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 16
|
-2.8 score on a scale
Standard Deviation 2.73
|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 20
|
-2.4 score on a scale
Standard Deviation 2.75
|
|
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Change at Week 24
|
-2.8 score on a scale
Standard Deviation 2.48
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable OTE data.
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.
Outcome measures
| Measure |
Cryoablation
n=64 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
|
|---|---|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Better than the Last Visit, Week 1
|
60.9 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Better than the Last Visit, Week 4
|
58.6 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Better than the Last Visit, Week 8
|
48.1 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Better than the Last Visit, Week 12
|
39.0 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Better than the Last Visit, Week 16
|
38.5 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Better than the Last Visit, Week 20
|
27.0 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Better than the Last Visit, Week 24
|
29.7 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Same as the Last Visit, Week 1
|
26.6 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Same as the Last Visit, Week 4
|
24.1 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Same as the Last Visit, Week 8
|
36.5 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Same as the Last Visit, Week 12
|
51.2 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Same as the Last Visit, Week 16
|
48.7 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Same as the Last Visit, Week 20
|
56.8 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Same as the Last Visit, Week 24
|
56.8 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Worse than the Last Visit, Week 1
|
12.5 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Worse than the Last Visit, Week 4
|
12.1 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Worse than the Last Visit, Week 8
|
13.5 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Worse than the Last Visit, Week 12
|
9.8 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Worse than the Last Visit, Week 16
|
12.8 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Worse than the Last Visit, Week 20
|
13.5 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Worse than the Last Visit, Week 24
|
10.8 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Missing, Week 1
|
0 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Missing, Week 4
|
5.2 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Missing, Week 8
|
1.9 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Missing, Week 12
|
0 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Missing, Week 16
|
0 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Missing, Week 20
|
2.7 percentage of participants
|
|
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Missing, Week 24
|
2.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 30 days post-cryoablationPopulation: Participants for whom received the complete study cryoablation procedure (Safety Population).
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.
Outcome measures
| Measure |
Cryoablation
n=65 Participants
All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.
|
|---|---|
|
Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
Intra-operative non-serious adverse event
|
3 Participants
|
|
Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
Post-operative non-serious adverse event
|
3 Participants
|
|
Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
Non-serious event after discharge within 30 days
|
8 Participants
|
|
Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
Serious adverse event
|
3 Participants
|
|
Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
Unanticipated adverse device effect
|
0 Participants
|
Adverse Events
Cryoablation
Serious events: 3 serious events
Other events: 13 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Cryoablation
n=65 participants at risk
All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Injury, poisoning and procedural complications
Burn
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Vascular disorders
Hematoma
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
Other adverse events
| Measure |
Cryoablation
n=65 participants at risk
All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators.
|
|---|---|
|
Cardiac disorders
Pericardial Effusion
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
General disorders
Fatigue
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
General disorders
Localized Edema
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
General disorders
Pain at needle site
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.1%
2/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Nervous system disorders
Neuralgia
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Vascular disorders
Hypotension
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
|
Vascular disorders
Hematoma
|
1.5%
1/65 • Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).
|
Additional Information
Sr. Clinical Trial Specialist
Galil Medical, a wholly owned indirect subsidiary of Boston Scientific
Phone: 651-287-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Galil Medical can require Investigator to postpone publications/presentations for up to 12 months so data from all sites can be published. Galil Medical will limit review of Investigator's draft to confirm Confidential Information is not being disclosed. If Galil Medical notes publishing Study results may affect obtaining a patent, Investigator may not publish for up to 60 days until patent application is filed. Investigator will acknowledge Galil Medical in any publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER