Trial Outcomes & Findings for Safety and Efficacy of Cryoablation for Metastatic Lung Tumors (NCT NCT01307501)
NCT ID: NCT01307501
Last Updated: 2021-07-19
Results Overview
Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or \<25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline and Month 60
Results posted on
2021-07-19
Participant Flow
Unit of analysis: Index Tumors
Participant milestones
| Measure |
Cryoablation
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Overall Study
STARTED
|
40 60
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Overall Study
Intent-to-Treat (ITT) Population
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40 60
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Overall Study
COMPLETED
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17 23
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Overall Study
NOT COMPLETED
|
23 37
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Reasons for withdrawal
| Measure |
Cryoablation
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Overall Study
Treatment Failure
|
1
|
|
Overall Study
Death
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20
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Overall Study
Lost to Follow-up
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1
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Overall Study
Starting Hospice
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1
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Baseline Characteristics
Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
Baseline characteristics by cohort
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Age, Continuous
|
62.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
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Sex: Female, Male
Female
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16 Participants
n=5 Participants
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|
Sex: Female, Male
Male
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24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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19 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Black or African American
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2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
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Eastern Cooperative Oncology Group (ECOG) Performance Status
|
0.3 score on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
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|
Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale
|
95.5 score on a scale
STANDARD_DEVIATION 8.1 • n=5 Participants
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|
Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
Physical Functioning
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71.2 score on a scale
STANDARD_DEVIATION 34.9 • n=5 Participants
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Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
Role Physical
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62.1 score on a scale
STANDARD_DEVIATION 29.7 • n=5 Participants
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Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
Bodily Pain
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77.3 score on a scale
STANDARD_DEVIATION 26.8 • n=5 Participants
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Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
Social Functioning
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80.5 score on a scale
STANDARD_DEVIATION 26.7 • n=5 Participants
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Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
Mental Health
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69.5 score on a scale
STANDARD_DEVIATION 18.2 • n=5 Participants
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Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
Role Emotional
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78.4 score on a scale
STANDARD_DEVIATION 21.0 • n=5 Participants
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Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
Vitality
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57.8 score on a scale
STANDARD_DEVIATION 22.4 • n=5 Participants
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Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure
General Health Perception
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63.9 score on a scale
STANDARD_DEVIATION 23.3 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and Month 60Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or \<25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
Outcome measures
| Measure |
Cryoablation
n=60 Tumors
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
Local Control, Month 60
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80.0 percentage of tumors
Interval 56.3 to 94.3
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
Complete Response, Month 60
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45.0 percentage of tumors
Interval 23.1 to 68.5
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
Partial Response, Month 60
|
15.0 percentage of tumors
Interval 3.2 to 37.9
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
Stable Disease, Month 60
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20.0 percentage of tumors
Interval 5.7 to 43.7
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60
Local Failure, Month 60
|
20.0 percentage of tumors
Interval 5.7 to 43.7
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SECONDARY outcome
Timeframe: Baseline and Months 3, 6, 12, 24, 36, and 48Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
Local tumor control was achieved if the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of the greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or \<25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
Outcome measures
| Measure |
Cryoablation
n=60 Tumors
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Control, Month 3
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46.4 percentage of tumors
Interval 33.0 to 60.3
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Control, Month 6
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66.7 percentage of tumors
Interval 52.9 to 78.6
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Control, Month 12
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80.4 percentage of tumors
Interval 66.9 to 90.2
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Control, Month 24
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87.5 percentage of tumors
Interval 73.2 to 95.8
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Control, Month 48
|
90.9 percentage of tumors
Interval 70.8 to 98.9
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Control, Month 36
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90.3 percentage of tumors
Interval 74.2 to 98.0
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Complete Response, Month 3
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5.4 percentage of tumors
Interval 1.1 to 14.9
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Complete Response, Month 6
|
15.8 percentage of tumors
Interval 7.5 to 27.9
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Complete Response, Month 12
|
23.5 percentage of tumors
Interval 12.8 to 37.5
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Complete Response, Month 24
|
40.0 percentage of tumors
Interval 24.9 to 56.7
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Complete Response, Month 36
|
38.7 percentage of tumors
Interval 21.8 to 57.8
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Complete Response, Month 48
|
40.9 percentage of tumors
Interval 20.7 to 63.6
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Partial Response, Month 3
|
3.6 percentage of tumors
Interval 0.4 to 12.3
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Partial Response, Month 6
|
10.5 percentage of tumors
Interval 4.0 to 21.5
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Partial Response, Month 12
|
15.7 percentage of tumors
Interval 7.0 to 28.6
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Partial Response, Month 24
|
10.0 percentage of tumors
Interval 2.8 to 23.7
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Partial Response, Month 36
|
16.1 percentage of tumors
Interval 5.5 to 33.7
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Partial Response, Month 48
|
22.7 percentage of tumors
Interval 7.8 to 45.4
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Stable Disease, Month 3
|
37.5 percentage of tumors
Interval 24.9 to 51.5
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Stable Disease, Month 6
|
40.4 percentage of tumors
Interval 27.6 to 54.2
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Stable Disease, Month 12
|
41.2 percentage of tumors
Interval 27.6 to 55.8
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|
Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Stable Disease, Month 24
|
37.5 percentage of tumors
Interval 22.7 to 54.2
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Stable Disease, Month 36
|
35.5 percentage of tumors
Interval 19.2 to 54.6
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Stable Disease, Month 48
|
27.3 percentage of tumors
Interval 10.7 to 50.2
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Failure, Month 3
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53.6 percentage of tumors
Interval 39.7 to 67.0
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Failure, Month 6
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33.3 percentage of tumors
Interval 21.4 to 47.1
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Failure, Month 12
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19.6 percentage of tumors
Interval 9.8 to 33.1
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Failure, Month 24
|
12.5 percentage of tumors
Interval 4.2 to 26.8
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Failure, Month 36
|
9.7 percentage of tumors
Interval 2.0 to 25.8
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Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48
Local Failure, Month 48
|
9.1 percentage of tumors
Interval 1.1 to 29.2
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SECONDARY outcome
Timeframe: Up to Month 60Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
Disease-specific survival was analyzed as time in days from study cryoablation to participant death due to lung cancer. All deaths with documented lung disease progression were categorized as disease-specific deaths for this analysis. Participants who were alive were censored at the date of their last visit. Participants who died from causes other than lung cancer and did not have documented disease progression were censored at the time of death.
Outcome measures
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Overall Disease-Specific Participant Survival Post-Cryoablation
Week 1
|
100 percentage of participants
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Overall Disease-Specific Participant Survival Post-Cryoablation
Month 1
|
100 percentage of participants
|
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Overall Disease-Specific Participant Survival Post-Cryoablation
Month 3
|
100 percentage of participants
|
|
Overall Disease-Specific Participant Survival Post-Cryoablation
Month 6
|
100 percentage of participants
|
|
Overall Disease-Specific Participant Survival Post-Cryoablation
Month 12
|
100 percentage of participants
|
|
Overall Disease-Specific Participant Survival Post-Cryoablation
Month 24
|
86.5 percentage of participants
|
|
Overall Disease-Specific Participant Survival Post-Cryoablation
Month 36
|
74.8 percentage of participants
|
|
Overall Disease-Specific Participant Survival Post-Cryoablation
Month 48
|
71.5 percentage of participants
|
|
Overall Disease-Specific Participant Survival Post-Cryoablation
Month 60
|
55.3 percentage of participants
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SECONDARY outcome
Timeframe: Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days)Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement that met the definition of local tumor failure. Local tumor failure defined as a \>20% increase from baseline in the sum of the largest diameter of all targeted tumors. Participants without disease recurrence or progression were censored at the date of their last visit or their date of death due to any cause. The percentage of participants with disease recurrence or progression after the study cryoablation procedure at the specified number of days is presented.
Outcome measures
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Baseline
|
0 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Week 1 (7 days)
|
0 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 1 (30 days)
|
0 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 3 (90 days)
|
0 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 6 (180 days)
|
2.5 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 12 (365 days)
|
5.1 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 24 (730 days)
|
10.7 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 36 (1095 days)
|
10.7 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 48 (1460 days)
|
10.7 percentage of participants
|
|
Time in Days to Disease Recurrence or Progression Following Study Cryoablation
Month 60 (1825 days)
|
21.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
ECOG Performance Status defined as a set of criteria with corresponding scores used by the Investigator to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. ECOG Performance Status Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.
Outcome measures
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
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|---|---|
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Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Week 1
|
0.1 score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 1
|
0 score on a scale
Standard Deviation 0.4
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 3
|
0.2 score on a scale
Standard Deviation 0.4
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 6
|
0.1 score on a scale
Standard Deviation 0.4
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 12
|
0.2 score on a scale
Standard Deviation 0.6
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 24
|
0.2 score on a scale
Standard Deviation 0.6
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 36
|
-0.1 score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 48
|
0.2 score on a scale
Standard Deviation 0.8
|
|
Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 60
|
0.6 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
The KPS Scale is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. KPS may be used to determine a participant's prognosis, to measure changes in a participant's ability to function.
Outcome measures
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
|
|---|---|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 48
|
5.0 score on a scale
Standard Deviation 5.5
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Baseline
|
95.5 score on a scale
Standard Deviation 8.1
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Week 1
|
-1.8 score on a scale
Standard Deviation 6.1
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 1
|
-0.9 score on a scale
Standard Deviation 5.3
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 3
|
-1.6 score on a scale
Standard Deviation 6.3
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 6
|
0.3 score on a scale
Standard Deviation 7.2
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 12
|
-0.5 score on a scale
Standard Deviation 8.4
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 24
|
4.4 score on a scale
Standard Deviation 7.3
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 36
|
7.8 score on a scale
Standard Deviation 4.4
|
|
Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60
Change at Month 60
|
6.7 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses eight domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality and general health perception). Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant.
Outcome measures
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
|
|---|---|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 6
|
-2.7 score on a scale
Standard Deviation 24.4
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 12
|
-3.8 score on a scale
Standard Deviation 21.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 24
|
-11.5 score on a scale
Standard Deviation 24.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 36
|
-11.3 score on a scale
Standard Deviation 27.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 48
|
-8.9 score on a scale
Standard Deviation 15.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 60
|
-22.9 score on a scale
Standard Deviation 26.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 1
|
-6.0 score on a scale
Standard Deviation 22.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 3
|
-9.3 score on a scale
Standard Deviation 19.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 6
|
-6.5 score on a scale
Standard Deviation 22.6
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 12
|
-10.2 score on a scale
Standard Deviation 24.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 24
|
-14.6 score on a scale
Standard Deviation 22.5
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 36
|
-2.5 score on a scale
Standard Deviation 27.5
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 48
|
-7.1 score on a scale
Standard Deviation 23.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Vitality, Change at Month 60
|
-4.2 score on a scale
Standard Deviation 29.2
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 1
|
-3.8 score on a scale
Standard Deviation 19.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 3
|
2.4 score on a scale
Standard Deviation 26.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 6
|
0 score on a scale
Standard Deviation 23.5
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 60
|
-4.2 score on a scale
Standard Deviation 25.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 1
|
-9.2 score on a scale
Standard Deviation 25.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 3
|
-3.7 score on a scale
Standard Deviation 21.6
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 6
|
-9.8 score on a scale
Standard Deviation 24.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 12
|
-7.6 score on a scale
Standard Deviation 19.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 24
|
-18.8 score on a scale
Standard Deviation 32.2
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 36
|
-5.0 score on a scale
Standard Deviation 30.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 48
|
0 score on a scale
Standard Deviation 28.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Bodily Pain, Change at Month 60
|
-8.3 score on a scale
Standard Deviation 49.2
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 1
|
-8.6 score on a scale
Standard Deviation 26.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 3
|
-3.7 score on a scale
Standard Deviation 23.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 6
|
-4.6 score on a scale
Standard Deviation 22.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 12
|
-11.4 score on a scale
Standard Deviation 24.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 24
|
-12.5 score on a scale
Standard Deviation 32.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 36
|
-2.5 score on a scale
Standard Deviation 24.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 48
|
-3.6 score on a scale
Standard Deviation 39.3
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Social Functioning, Change at Month 60
|
-12.5 score on a scale
Standard Deviation 37.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 1
|
1.7 score on a scale
Standard Deviation 16.3
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 3
|
0.9 score on a scale
Standard Deviation 12.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 6
|
-1.4 score on a scale
Standard Deviation 10.6
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 12
|
-0.6 score on a scale
Standard Deviation 20.6
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 24
|
-3.1 score on a scale
Standard Deviation 17.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 36
|
3.8 score on a scale
Standard Deviation 15.6
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 48
|
8.9 score on a scale
Standard Deviation 9.4
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Mental Health, Change at Month 60
|
0 score on a scale
Standard Deviation 13.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 1
|
-3.3 score on a scale
Standard Deviation 20.5
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Emotional, Change at Month 3
|
-11.6 score on a scale
Standard Deviation 23.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 12
|
-5.2 score on a scale
Standard Deviation 31.4
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 24
|
-11.3 score on a scale
Standard Deviation 22.2
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 36
|
-14.5 score on a scale
Standard Deviation 24.1
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 48
|
-14.3 score on a scale
Standard Deviation 28.9
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
General Health Perception, Change at Month 60
|
-22.5 score on a scale
Standard Deviation 33.6
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 1
|
-10.0 score on a scale
Standard Deviation 24.2
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 3
|
-12.0 score on a scale
Standard Deviation 24.4
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 6
|
-12.5 score on a scale
Standard Deviation 33.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 12
|
-23.9 score on a scale
Standard Deviation 38.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 24
|
-10.4 score on a scale
Standard Deviation 44.5
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 36
|
-12.5 score on a scale
Standard Deviation 31.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 48
|
-10.7 score on a scale
Standard Deviation 31.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Physical Functioning, Change at Month 60
|
-12.5 score on a scale
Standard Deviation 54.2
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 1
|
4.2 score on a scale
Standard Deviation 24.2
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 3
|
-1.9 score on a scale
Standard Deviation 21.0
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 6
|
-0.4 score on a scale
Standard Deviation 19.7
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 12
|
-2.2 score on a scale
Standard Deviation 26.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 24
|
5.2 score on a scale
Standard Deviation 23.5
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 36
|
5.0 score on a scale
Standard Deviation 25.8
|
|
Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60
Role Physical, Change at Month 48
|
3.6 score on a scale
Standard Deviation 35.9
|
SECONDARY outcome
Timeframe: Up to 60 monthsPopulation: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
A technically successful treatment was defined by an ablation volume encompassing the tumor with at least a 5 mm margin. Technical success was calculated on a per tumor level as well as a participant level. To be considered a technical success on a participant level, all tumors treated during the baseline procedure were required to meet the technical success criteria (that is, an ablation volume encompassing the tumor with at least a 5 mm margin).
Outcome measures
| Measure |
Cryoablation
n=60 Tumors
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
|
|---|---|
|
Cryoablation Technical Success of the Study Cryoablation Procedure
|
100 percentage of tumors
|
SECONDARY outcome
Timeframe: Baseline up to 30 days post-cryoablationPopulation: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. UADE was any serious adverse effect, any life-threatening problem or death caused by or associated with a device, if it was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device. The AEs that are presented were considered related to the cryoablation procedure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
|
|---|---|
|
Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)
Intra-operative nonserious AE (NSAE)
|
23 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)
Post-operative NSAE, prior to discharge
|
9 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)
Post-operative NSAE within 30 days of procedure
|
19 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)
Serious AE
|
6 Participants
|
|
Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE)
UADE
|
0 Participants
|
SECONDARY outcome
Timeframe: Months 3, 6, 12, 24, 36, 48, and 60Population: Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point.
Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented.
Outcome measures
| Measure |
Cryoablation
n=40 Participants
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
|
|---|---|
|
Metastatic Disease Spread as Measured by Imaging
Month 3
|
16 Participants
|
|
Metastatic Disease Spread as Measured by Imaging
Month 6
|
14 Participants
|
|
Metastatic Disease Spread as Measured by Imaging
Month 12
|
14 Participants
|
|
Metastatic Disease Spread as Measured by Imaging
Month 24
|
10 Participants
|
|
Metastatic Disease Spread as Measured by Imaging
Month 36
|
9 Participants
|
|
Metastatic Disease Spread as Measured by Imaging
Month 48
|
7 Participants
|
|
Metastatic Disease Spread as Measured by Imaging
Month 60
|
6 Participants
|
Adverse Events
Cryoablation
Serious events: 6 serious events
Other events: 32 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Cryoablation
n=40 participants at risk
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
|
|---|---|
|
Infections and infestations
Appendicitis
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.5%
3/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Vascular disorders
Bilateral subdural hematoma
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
Other adverse events
| Measure |
Cryoablation
n=40 participants at risk
Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. 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. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Fever
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Flu like symptoms
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Pain
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
General disorders
Pain at procedure site
|
5.0%
2/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
Lung infection
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Injury, poisoning and procedural complications
Burn
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
5.0%
2/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
2/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Musculoskeletal and connective tissue disorders
Pain in left arm
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
6.2%
1/16 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar hemorrhage
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
2/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.5%
1/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
27.5%
11/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural hemorrhage
|
5.0%
2/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
47.5%
19/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
5.0%
2/40 • Baseline up to Month 60
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
|
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 BTG can require Investigator to postpone publications/presentations for up to 12 months so data from all sites can be published. BTG will limit review of Investigator's draft to confirm Confidential Information is not being disclosed. If BTG notes publishing Study results may affect obtaining a patent, Investigator will not publish for up to 60 days until patent application is filed. Investigator will acknowledge BTG in any publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER