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This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics).
Participants with painful metastatic lesions involving bone who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy were offered enrollment into the study. Participants agreeing to participate will read and sign an informed consent form and thus become participants in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Participants will have one cryoablation procedure and will be followed for up to 6 months for palliation of pain, quality of life, and analgesic usage. Baseline and follow-up data will be collected for each participant via a web-based electronic data collection tool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation | Experimental | All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | The application of repeated freeze and thaw cycles to the identified tissues. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8 | The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2-point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Week 8 is presented. | Baseline, Week 8 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Respond to the Cryoablation Therapy | Response was defined as a ≥2-point reduction from baseline in worst pain in last 24 hours with stable medication use (that is, no more than a 25% increase in Morphine Equivalent Daily Dose [MEDD] from baseline). MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Pain was assessed using BPI-SF with a scale of 0 (no pain) to 10 (worst pain imaginable). Percentages are proportion of responders based on logistic regression after MCMC, multiple imputation. For visits where medication use is not available, morphine equivalent values from the most recent non-missing visit are used. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack Jennings, MD | Washington University Saint Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1387912 | Background | Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8. | |
| 9224575 | Background | Phillips DR, Milim SJ, Nathanson HG, Haselkorn JS. Experience with laparoscopic leiomyoma coagulation and concomitant operative hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Aug;4(4):425-33. doi: 10.1016/s1074-3804(05)80034-9. |
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Discontinuation reasons reported below of death, withdrew consent, oncologist cancelled study cryoablation, required radiofrequency ablation, negative biopsy, protocol violation, and received radiation treatment include 7 enrolled participants who were discontinued before treatment was attempted. No other data is reported for these 7 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryoablation | All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2017 | Aug 7, 2019 |
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| Baseline and Week 8 |
| Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24. | Quality of Life (QoL) as indicated by the change in overall average BPI-SF Pain Interference score from baseline to each visit was evaluated at Weeks 1, 4, 8, 12, 16, 20, and 24. Using the BPI-SF, participants rated the amount of interference from pain on a scale of 0 (does not interfere) to 10 (completely interferes) for the following areas: general activity. mood, walking ability, relations, sleep, and enjoyment. For participants with responses ≥50% of the areas at a time point, a total Pain Interference score, which was the mean of the individual area scores, was calculated programmatically at that point. Baseline data and change from Baseline data is presented. | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24 | The Karnofsky Performance Status (KPS) scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities from Baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation. Baseline data and change from Baseline data is presented. | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Number of Participants With Additional Pain Therapies | Participants requiring additional targeted therapies to the index tumor (for example, cryoablation, radio frequency ablation [RFA], microwave ablation [MWA], high intensity focused ultrasound [HIFU], radiation, surgery) were withdrawn from the study. Other therapies, including pain medication and chemotherapy, were permitted during the study. All additional therapies were recorded. The number of participants requiring new therapy since the last visit is presented. | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24 | Analgesic (that is, opioid or non-steroidal anti-inflammatory drug [NSAID]) use and the reason for each change in analgesic dose was recorded at each study visit. Opioid medications were converted to a standardized MEDD. MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Baseline data and change from Baseline data is presented. | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24 | The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2 point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Weeks 1, 4, 12, 16, 20, and 24 is presented. | Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24 |
| Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24 | The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported average pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Baseline data and change from Baseline data is presented. | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24 | Participants performed a self-assessment of OTE at Week 1 and every visit thereafter (Weeks 4, 8, 12, 16, 20 and 24). Participants were asked their opinion of the effect cryoablation procedure had on their wellbeing and asked to compare their wellbeing at the time of each follow-up visit to the previous visit or phone call. The wellbeing categories were "Better than the Last Visit," "The Same as the Last Visit," and "Worse than the Last Visit." The percentage of participants that were reported for each wellbeing category at Weeks 1, 4, 8, 12, 16, 20, and 24 is presented. | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
| Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects | The number of participants with an intra-operative non-serious adverse event, a post-operative, a non-serious adverse event, a serious adverse event, or unanticipated adverse device effects related to the cryoablation procedure is presented. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Baseline up to 30 days post-cryoablation |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Crittenton Hospital | Rochester | Michigan | 48307 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Institut Bergonié | Bordeaux | 33000 | France |
| Centre Léon Bérard | Lyon | 69373 | France |
| University Hospital of Strasbourg | Strasbourg | 67091 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| 8786884 | Background | Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available. |
| 13881139 | Background | COOPER IS, LEE AS. Cryostatic congelation: a system for producing a limited, controlled region of cooling or freezing of biologic tissues. J Nerv Ment Dis. 1961 Sep;133:259-63. No abstract available. |
| 12206845 | Background | Saliken JC, Donnelly BJ, Rewcastle JC. The evolution and state of modern technology for prostate cryosurgery. Urology. 2002 Aug;60(2 Suppl 1):26-33. doi: 10.1016/s0090-4295(02)01681-3. |
| 10389867 | Background | Rewcastle JC, Sandison GA, Saliken JC, Donnelly BJ, McKinnon JG. Considerations during clinical operation of two commercially available cryomachines. J Surg Oncol. 1999 Jun;71(2):106-11. doi: 10.1002/(sici)1096-9098(199906)71:23.0.co;2-z. |
| 9354166 | Background | Rewcastle JC, Hahn LJ, Saliken JC, McKinnon JG. Use of a moratorium to achieve consistent liquid nitrogen cryoprobe performance. J Surg Oncol. 1997 Oct;66(2):110-3. doi: 10.1002/(sici)1096-9098(199710)66:23.0.co;2-g. |
| 3197439 | Background | Gage AA. Current progress in cryosurgery. Cryobiology. 1988 Oct;25(5):483-6. doi: 10.1016/0011-2240(88)90056-9. |
| 3979086 | Background | Gage AA, Guest K, Montes M, Caruana JA, Whalen DA Jr. Effect of varying freezing and thawing rates in experimental cryosurgery. Cryobiology. 1985 Apr;22(2):175-82. doi: 10.1016/0011-2240(85)90172-5. |
| 1582235 | Background | Gage AA. Progress in cryosurgery. Cryobiology. 1992 Apr;29(2):300-4. doi: 10.1016/0011-2240(92)90030-6. |
| 8050273 | Background | Homasson JP, Thiery JP, Angebault M, Ovtracht L, Maiwand O. The operation and efficacy of cryosurgical, nitrous oxide-driven cryoprobe. I. Cryoprobe physical characteristics: their effects on cell cryodestruction. Cryobiology. 1994 Jun;31(3):290-304. doi: 10.1006/cryo.1994.1035. |
| 8263903 | Background | Hamilton A, Hu J. An electronic cryoprobe for cryosurgery using heat pipes and thermoelectric coolers: a preliminary report. J Med Eng Technol. 1993 May-Jun;17(3):104-9. doi: 10.3109/03091909309016215. |
| 9181244 | Background | Rabin Y, Julian TB, Wolmark N. A compact cryosurgical apparatus for minimally invasive procedures. Biomed Instrum Technol. 1997 May-Jun;31(3):251-8. |
| 8812089 | Background | Rabin Y, Coleman R, Mordohovich D, Ber R, Shitzer A. A new cryosurgical device for controlled freezing. Cryobiology. 1996 Feb;33(1):93-105. doi: 10.1006/cryo.1996.0010. |
| 2992882 | Background | Rand RW, Rand RP, Eggerding FA, Field M, Denbesten L, King W, Camici S. Cryolumpectomy for breast cancer: an experimental study. Cryobiology. 1985 Aug;22(4):307-18. doi: 10.1016/0011-2240(85)90178-6. |
| 971585 | Background | Miller RH, Mazur P. Survival of frozen-thawed human red cells as a function of cooling and warming velocities. Cryobiology. 1976 Aug;13(4):404-14. doi: 10.1016/0011-2240(76)90096-1. |
| 19833119 | Background | Gage AA, Baust JM, Baust JG. Experimental cryosurgery investigations in vivo. Cryobiology. 2009 Dec;59(3):229-43. doi: 10.1016/j.cryobiol.2009.10.001. Epub 2009 Oct 13. |
| 18070688 | Background | McTaggart RA, Dupuy DE. Thermal ablation of lung tumors. Tech Vasc Interv Radiol. 2007 Jun;10(2):102-13. doi: 10.1053/j.tvir.2007.09.004. |
| 18070690 | Background | Callstrom MR, Charboneau JW. Image-guided palliation of painful metastases using percutaneous ablation. Tech Vasc Interv Radiol. 2007 Jun;10(2):120-31. doi: 10.1053/j.tvir.2007.09.003. |
| 10796822 | Background | McQuay HJ, Collins SL, Carroll D, Moore RA. Radiotherapy for the palliation of painful bone metastases. Cochrane Database Syst Rev. 2000;(2):CD001793. doi: 10.1002/14651858.CD001793. |
| 17057075 | Background | Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80. doi: 10.1148/radiol.2412051247. |
| 11110597 | Background | Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463. |
| 14722039 | Background | Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Gronemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. doi: 10.1200/JCO.2004.03.097. |
| 12091666 | Background | Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97. doi: 10.1148/radiol.2241011613. |
| 18695866 | Background | Belfiore G, Tedeschi E, Ronza FM, Belfiore MP, Della Volpe T, Zeppetella G, Rotondo A. Radiofrequency ablation of bone metastases induces long-lasting palliation in patients with untreatable cancer. Singapore Med J. 2008 Jul;49(7):565-70. |
| 24760791 | Background | Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014 Apr 23;106(5):dju082. doi: 10.1093/jnci/dju082. |
| 16598666 | Background | Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. doi: 10.1055/s-2006-939031. Epub 2006 Apr 5. |
| 18054665 | Background | Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. doi: 10.1067/j.cpradiol.2007.05.001. |
| 10431856 | Background | Maiwand MO. The role of cryosurgery in palliation of tracheo-bronchial carcinoma. Eur J Cardiothorac Surg. 1999 Jun;15(6):764-8. doi: 10.1016/s1010-7940(99)00121-9. |
| 8521698 | Background | Maiwand MO, Homasson JP. Cryotherapy for tracheobronchial disorders. Clin Chest Med. 1995 Sep;16(3):427-43. |
| 6791555 | Background | Sanderson DR, Neel HB 3rd, Fontana RS. Bronchoscopic cryotherapy. Ann Otol Rhinol Laryngol. 1981 Jul-Aug;90(4 Pt 1):354-8. doi: 10.1177/000348948109000414. |
| 8996403 | Background | Cozzi PJ, Lynch WJ, Collins S, Vonthethoff L, Morris DL. Renal cryotherapy in a sheep model; a feasibility study. J Urol. 1997 Feb;157(2):710-2. |
| 6024400 | Background | Gage AA, Fazekas G, Riley EE Jr. Freezing injury to large blood vessels in dogs. With comments on the effect of experimental freezing of bile ducts. Surgery. 1967 May;61(5):748-54. No abstract available. |
| 513700 | Background | Gage AM, Montes M, Gage AA. Freezing the canine thoracic aorta in situ. J Surg Res. 1979 Nov;27(5):331-40. doi: 10.1016/0022-4804(79)90149-5. No abstract available. |
| 10399979 | Background | Ladd AP, Rescorla FJ, Baust JG, Callahan M, Davis M, Grosfeld JL. Cryosurgical effects on growing vessels. Am Surg. 1999 Jul;65(7):677-82. |
| 6034857 | Background | Mandeville AF, McCabe BF. Some observations on the cryobiology of blood vessels. Laryngoscope. 1967 Aug;77(8):1328-50. doi: 10.1288/00005537-196708000-00009. No abstract available. |
| 23065947 | Background | Callstrom MR, Dupuy DE, Solomon SB, Beres RA, Littrup PJ, Davis KW, Paz-Fumagalli R, Hoffman C, Atwell TD, Charboneau JW, Schmit GD, Goetz MP, Rubin J, Brown KJ, Novotny PJ, Sloan JA. Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial. Cancer. 2013 Mar 1;119(5):1033-41. doi: 10.1002/cncr.27793. Epub 2012 Oct 12. |
| 17062707 | Background | Cleeland CS. The measurement of pain from metastatic bone disease: capturing the patient's experience. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6236s-6242s. doi: 10.1158/1078-0432.CCR-06-0988. |
| 33817650 | Derived | Jennings JW, Prologo JD, Garnon J, Gangi A, Buy X, Palussiere J, Kurup AN, Callstrom M, Genshaft S, Abtin F, Huang AJ, Iannuccilli J, Pilleul F, Mastier C, Littrup PJ, de Baere T, Deschamps F. Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study. Radiol Imaging Cancer. 2021 Feb 12;3(2):e200101. doi: 10.1148/rycan.2021200101. eCollection 2021 Mar. |
| Intent-to-Treat (ITT) Population |
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| Participants Discontinued Pre-Treatment |
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| Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cryoablation | All participants had one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8 | The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2-point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Week 8 is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population). The Markov chain Monte Carlo (MCMC) method of imputation was used for imputation of missing BPI-SF values with 50 imputations to be performed. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 8 |
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| Other Pre-specified | Percentage of Participants Who Respond to the Cryoablation Therapy | Response was defined as a ≥2-point reduction from baseline in worst pain in last 24 hours with stable medication use (that is, no more than a 25% increase in Morphine Equivalent Daily Dose [MEDD] from baseline). MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Pain was assessed using BPI-SF with a scale of 0 (no pain) to 10 (worst pain imaginable). Percentages are proportion of responders based on logistic regression after MCMC, multiple imputation. For visits where medication use is not available, morphine equivalent values from the most recent non-missing visit are used. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population). | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 8 |
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| Other Pre-specified | Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24. | Quality of Life (QoL) as indicated by the change in overall average BPI-SF Pain Interference score from baseline to each visit was evaluated at Weeks 1, 4, 8, 12, 16, 20, and 24. Using the BPI-SF, participants rated the amount of interference from pain on a scale of 0 (does not interfere) to 10 (completely interferes) for the following areas: general activity. mood, walking ability, relations, sleep, and enjoyment. For participants with responses ≥50% of the areas at a time point, a total Pain Interference score, which was the mean of the individual area scores, was calculated programmatically at that point. Baseline data and change from Baseline data is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable interference from pain scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
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| Other Pre-specified | Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24 | The Karnofsky Performance Status (KPS) scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities from Baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation. Baseline data and change from Baseline data is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable KPS scores. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
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| Other Pre-specified | Number of Participants With Additional Pain Therapies | Participants requiring additional targeted therapies to the index tumor (for example, cryoablation, radio frequency ablation [RFA], microwave ablation [MWA], high intensity focused ultrasound [HIFU], radiation, surgery) were withdrawn from the study. Other therapies, including pain medication and chemotherapy, were permitted during the study. All additional therapies were recorded. The number of participants requiring new therapy since the last visit is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable additional pain therapy data. | Posted | Count of Participants | Participants | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
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| Other Pre-specified | Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24 | Analgesic (that is, opioid or non-steroidal anti-inflammatory drug [NSAID]) use and the reason for each change in analgesic dose was recorded at each study visit. Opioid medications were converted to a standardized MEDD. MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Baseline data and change from Baseline data is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable MEDD and NSAID data. | Posted | Mean | Standard Deviation | milligrams (mg) | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
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| Other Pre-specified | Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24 | The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2 point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Weeks 1, 4, 12, 16, 20, and 24 is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable worse pain scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24 |
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| Other Pre-specified | Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24 | The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported average pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Baseline data and change from Baseline data is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable average pain scores. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
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| Other Pre-specified | Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24 | Participants performed a self-assessment of OTE at Week 1 and every visit thereafter (Weeks 4, 8, 12, 16, 20 and 24). Participants were asked their opinion of the effect cryoablation procedure had on their wellbeing and asked to compare their wellbeing at the time of each follow-up visit to the previous visit or phone call. The wellbeing categories were "Better than the Last Visit," "The Same as the Last Visit," and "Worse than the Last Visit." The percentage of participants that were reported for each wellbeing category at Weeks 1, 4, 8, 12, 16, 20, and 24 is presented. | Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable OTE data. | Posted | Number | percentage of participants | Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 |
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| Other Pre-specified | Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects | The number of participants with an intra-operative non-serious adverse event, a post-operative, a non-serious adverse event, a serious adverse event, or unanticipated adverse device effects related to the cryoablation procedure is presented. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. | Participants for whom received the complete study cryoablation procedure (Safety Population). | Posted | Count of Participants | Participants | Baseline up to 30 days post-cryoablation |
|
Up to Week 24
All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population [N=65]).
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 | All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening. In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators. | 19 | 73 | 3 | 65 | 13 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Localized Edema | General disorders | Systematic Assessment |
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| Pain at needle site | General disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Buttock pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Specialist | Galil Medical, a wholly owned indirect subsidiary of Boston Scientific | 651-287-5000 | GalilClinical@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 18, 2016 | Aug 7, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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