Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 centimeter (cm). Participants will be followed 24 months post their cryoablation procedure.
Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation therapy, or a combination of treatments. However, several variables may exclude participants from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these participants, percutaneous cryoablation may be a suitable option.
Ablation of metastatic lung tumors is a rapidly expanding area within interventional oncology. Cryotherapy, radiofrequency, laser, and microwave have all been shown to be effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of the ability to visualize the ice under imaging guidance and the preservation of collagenous tissue structure. Cryoablation has been extensively performed in the prostate and kidney with favorable outcomes reported in the literature. More recently, cryoablation has been shown to be safe in the treatment of lung tumors with CT guidance.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Experimental | Participants will undergo 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 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. Tumors in both lungs are to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session will not be performed. All participants will receive cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors are to be completed within an 8-week window. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | Application of extremely cold temperatures to the identified tumor(s). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12 | Local tumor control defined as the absence of local treatment failure 12 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast. | Month 1 (Month 3 if Month 1 Data was missing) and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect | The number of participants with the following categories of adverse events is presented: an intra-operative, a post-operative, a serious adverse event, or an unanticipated adverse device effect. The adverse events that are presented are related to the cryoablation procedure. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control for Each Index Tumor at Month 18 and Month 24 | Local tumor control defined as the absence of local treatment failure 18 and 24 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thierry de Baere, MD | Gustave Roussy, Cancer Campus, Grand Paris | Study Chair |
| Matthew Callstrom, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States | ||
| Cancer Treatment Centers of America at Southeastern Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18442957 | Background | Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8(1):116-7. doi: 10.1102/1470-7330.2008.0015. | |
| 16714662 | Background | Ahmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6. doi: 10.2214/AJR.04.1068. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12 | Local tumor control defined as the absence of local treatment failure 12 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). Multiple imputation methods for missing data were applied. | Posted | Number | 95% Confidence Interval | percentage of tumors | Month 1 (Month 3 if Month 1 Data was missing) and Month 12 | Number of Tumors | Number of Tumors |
Baseline up to Month 24
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Tumors in both lungs were to be treated at an appropriate interval, determined on an individual basis. Treatment of bilateral index tumors in a single treatment session was not performed. All participants received cryoablation of up to 6 metastatic lung tumors. Treatment of all study index tumors was completed within an 8-week window. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Specialist | Galil Medical, a wholly owned indirect subsidiary of Boston Scientific | 651-287-5000 | GalilClinical@bsci.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2014 | Aug 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2017 | Aug 7, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline up to 30 days post-cryoablation |
| Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24 |
| Overall Participant Survival Post-cryoablation | Overall survival rate was defined as the time in days from the first cryoablation procedure to death. Participants who were alive were censored at the date of the last visit. | Up to Month 24 |
| Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s) | Time to metastatic lung disease progression beyond the index tumor was defined as the time in days from the first cryoablation procedure to metastatic disease beyond the index tumor site. Participants without metastatic lung disease progression were censored at the date of their last visit or their date of death (due to any cause). | Up to Month 24 |
| Time to Overall Cancer Progression | Time to overall cancer progression was defined as the time in days from the first cryoablation procedure to cancer progression (that is, any location of active cancer disease). Participants without cancer progression were censored at the date of their last visit or their date of death (due to any cause). | Up to Month 24 |
| Local Tumor Control With Additional Cryoablation Galil Medical Technology Treatment(s) of a Previously Treated Index Tumor | Local tumor control, defined as absence of local treatment failure 12 months following study cryoablation based on site-reported data, was achieved if 3-axis measurement (that is, greatest trans-axial diameter plus 2 perpendicular diameters) of a tumor at Month 12 was <20% larger than 3-axis measurement of the tumor at Month 1 following study cryoablation. Separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Follow-up visits were re-started after additional treatment, per study protocol and continued through the Month 24 visit after the last study cryoablation. Month 1 data served as baseline for analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at prior study visit and with repeat cryoablation procedures prior to Month 12 were counted as failures. Tumor measurement imaging performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast. | Up to Month 12 |
| Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease) | Time to untreatable metastatic lung disease control with cryoablation is defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated with cryoablation. The percentage of participants free from metastatic disease that is untreatable with cryoablation at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented. | Month 12 (Days 181-365) and Month 24 (Days 495-730) |
| Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease) | Time to untreatable metastatic lung disease control with focal therapy defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated by focal (for example, ablation, surgery, SBRT) intervention for control of metastatic lung disease. The percentage of participants free from metastatic disease that is untreatable with focal therapy at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented. | Month 12 (Days 181-365) and Month 24 (Days 495-730) |
| Cryoablation Technical Success at Month 1 | A technically successful treatment was defined by the presence of an ablation zone, ground glass opacity, or frank consolidation encompassing the targeted index tumor(s) at no later than the 1 month follow up visit after the cryoablation procedure. Technical success rates and 95% confidence intervals (CIs) were calculated using random effects logistic regression on a tumor level. | Up to Month 1 |
| Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24 | The 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 were 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. | Baseline, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 |
| Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3 | The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses 8 domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, general health perception). The shorter instrument provides a general measurement of quality of life. 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. | Baseline, Month 1 and Month 3 |
| Newnan |
| Georgia |
| 30265 |
| United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| New York Presbyterian Hospital - Cornell Medical Center | New York | New York | 10065 | United States |
| State University of New York at Stony Brook | Stony Brook | New York | 11794 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Inova Alexandria Hospital CVIR | Alexandria | Virginia | 22304 | United States |
| Institut Bergonié | Bordeaux | Aquitaine | 33070 | France |
| Institut Gustave Roussy | Villejuif | Île-de-France Region | 94805 | France |
| 16678583 | Background | Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13. doi: 10.1016/j.jtcvs.2005.12.051. |
| 15947313 | Background | Asimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14. doi: 10.1378/chest.127.6.2007. |
| 15798173 | Background | Wang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98. doi: 10.1148/radiol.2351030747. |
| 22265246 | Background | Inoue M, Nakatsuka S, Yashiro H, Ito N, Izumi Y, Yamauchi Y, Hashimoto K, Asakura K, Tsukada N, Kawamura M, Nomori H, Kuribayashi S. Percutaneous cryoablation of lung tumors: feasibility and safety. J Vasc Interv Radiol. 2012 Mar;23(3):295-302; quiz 305. doi: 10.1016/j.jvir.2011.11.019. Epub 2012 Jan 20. |
| 22096520 | Background | Yamauchi Y, Izumi Y, Kawamura M, Nakatsuka S, Yashiro H, Tsukada N, Inoue M, Asakura K, Nomori H. Percutaneous cryoablation of pulmonary metastases from colorectal cancer. PLoS One. 2011;6(11):e27086. doi: 10.1371/journal.pone.0027086. Epub 2011 Nov 9. |
| 23394762 | Background | Pusceddu C, Sotgia B, Fele RM, Melis L. CT-guided thin needles percutaneous cryoablation (PCA) in patients with primary and secondary lung tumors: a preliminary experience. Eur J Radiol. 2013 May;82(5):e246-53. doi: 10.1016/j.ejrad.2012.12.010. Epub 2013 Feb 8. |
| Entered Hospice or Similar Program |
|
| Index Tumor(s) Resected |
|
| Index Tumor was Primary Lung Cancer |
|
| Local therapy, not cryoablation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Index Tumors Per Participant | Count of Participants | Participants |
|
|
|
|
|
| Secondary | Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect | The number of participants with the following categories of adverse events is presented: an intra-operative, a post-operative, a serious adverse event, or an unanticipated adverse device effect. The adverse events that are presented are related to the cryoablation procedure. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population). | Posted | Count of Participants | Participants | Baseline up to 30 days post-cryoablation |
|
|
|
| Other Pre-specified | Local Tumor Control for Each Index Tumor at Month 18 and Month 24 | Local tumor control defined as the absence of local treatment failure 18 and 24 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). Multiple imputation methods for missing data were applied. | Posted | Number | 95% Confidence Interval | percentage of tumors | Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24 | Number of Tumors | Number of Tumors |
|
|
|
| Other Pre-specified | Overall Participant Survival Post-cryoablation | Overall survival rate was defined as the time in days from the first cryoablation procedure to death. Participants who were alive were censored at the date of the last visit. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). | Posted | Number | percentage of participants | Up to Month 24 |
|
|
|
| Other Pre-specified | Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s) | Time to metastatic lung disease progression beyond the index tumor was defined as the time in days from the first cryoablation procedure to metastatic disease beyond the index tumor site. Participants without metastatic lung disease progression were censored at the date of their last visit or their date of death (due to any cause). | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). | Posted | Median | 95% Confidence Interval | days | Up to Month 24 |
|
|
|
| Other Pre-specified | Time to Overall Cancer Progression | Time to overall cancer progression was defined as the time in days from the first cryoablation procedure to cancer progression (that is, any location of active cancer disease). Participants without cancer progression were censored at the date of their last visit or their date of death (due to any cause). | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). | Posted | Median | 95% Confidence Interval | days | Up to Month 24 |
|
|
|
| Other Pre-specified | Local Tumor Control With Additional Cryoablation Galil Medical Technology Treatment(s) of a Previously Treated Index Tumor | Local tumor control, defined as absence of local treatment failure 12 months following study cryoablation based on site-reported data, was achieved if 3-axis measurement (that is, greatest trans-axial diameter plus 2 perpendicular diameters) of a tumor at Month 12 was <20% larger than 3-axis measurement of the tumor at Month 1 following study cryoablation. Separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Follow-up visits were re-started after additional treatment, per study protocol and continued through the Month 24 visit after the last study cryoablation. Month 1 data served as baseline for analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at prior study visit and with repeat cryoablation procedures prior to Month 12 were counted as failures. Tumor measurement imaging performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and underwent an additional Cryoablation Galil Medical Technology Treatment. | Posted | Number | percentage of tumors | Up to Month 12 | Number of Tumors | Number of Tumors |
|
|
|
| Other Pre-specified | Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease) | Time to untreatable metastatic lung disease control with cryoablation is defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated with cryoablation. The percentage of participants free from metastatic disease that is untreatable with cryoablation at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) with available data at the respective time point. | Posted | Number | percentage of participants | Month 12 (Days 181-365) and Month 24 (Days 495-730) |
|
|
|
| Other Pre-specified | Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease) | Time to untreatable metastatic lung disease control with focal therapy defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated by focal (for example, ablation, surgery, SBRT) intervention for control of metastatic lung disease. The percentage of participants free from metastatic disease that is untreatable with focal therapy at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) with available data at the respective time point. | Posted | Number | percentage of participants | Month 12 (Days 181-365) and Month 24 (Days 495-730) |
|
|
|
| Other Pre-specified | Cryoablation Technical Success at Month 1 | A technically successful treatment was defined by the presence of an ablation zone, ground glass opacity, or frank consolidation encompassing the targeted index tumor(s) at no later than the 1 month follow up visit after the cryoablation procedure. Technical success rates and 95% confidence intervals (CIs) were calculated using random effects logistic regression on a tumor level. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). | Posted | Number | 95% Confidence Interval | percentage of tumors | Up to Month 1 | Number of Tumors | Number of Tumors |
|
|
|
| Other Pre-specified | Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24 | The 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 were 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. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and evaluable KPS scores. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Other Pre-specified | Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3 | The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses 8 domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, general health perception). The shorter instrument provides a general measurement of quality of life. 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. | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and evaluable SF-12 scores. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1 and Month 3 |
|
|
|
| 18 |
| 130 |
| 18 |
| 130 |
| 70 |
| 130 |
| Gait imbalance | General disorders | Systematic Assessment |
|
| Abdominal infection | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gaseous embolism | Vascular disorders | Systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Bilateral leg edema | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Systematic Assessment |
|
| Pain at needle site | General disorders | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Device related infection | Infections and infestations | Systematic Assessment |
|
| Hepatic infection | Infections and infestations | Systematic Assessment |
|
| MRSA infected decubitus ulcer | Infections and infestations | Systematic Assessment | Methicillin-resistant Staphylococcus aureus (MRSA) |
|
| Oropharyngeal candidiasis | Infections and infestations | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Steroid induced hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Radiculitis | Nervous system disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Diaphragm paralysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Left-sided pleuritic pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash on face and abdomen | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
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.
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Intra-operative serious adverse event |
|
| Post-operative serious adverse event |
|
| Unanticipated adverse device effect |
|
| Title | Measurements |
|---|---|
|
| 91-180 Days |
|
| 181-365 Days |
|
| 366-730 Days |
|
|
|
|
| Month 6 |
|
|
| Month 12 |
|
|
| Month 18 |
|
|
| Month 24 |
|
|
|
| Role Physical, Month 1 |
|
|
| Role Physical, Month 3 |
|
|
| Bodily Pain, Month 1 |
|
|
| Bodily Pain, Month 3 |
|
|
| Social Functioning, Month 1 |
|
|
| Social Functioning, Month 3 |
|
|
| Mental Health, Month 1 |
|
|
| Mental Health, Month 3 |
|
|
| Role Emotional, Month 1 |
|
|
| Role Emotional, Month 3 |
|
|
| Vitality, Month 1 |
|
|
| Vitality, Month 3 |
|
|
| General Health Perception, Month 1 |
|
|
| General Health Perception, Month 3 |
|
|