Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer

• Abdominal pain reduction following cryoablation of the celiac plexus [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Measured by the average difference of pre- and post-treatment worst pain in the last 24 hours (baseline), within 24 hours of the cryoablation procedure, 1 week, 4 weeks, 8 weeks and 12 weeks as measured on the numeric 0-10 Brief Pain Inventory (BPI) Scale
  
  

• Duration of abdominal pain relief [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Measured from the cryoablation procedure to the return of the abdominal pain
  
  
• Cryoablation Procedure Information [ Time Frame: During the procedure on the procedure day (an expected average of 3 hours) ] [ Designated as safety issue: No ]
  Number of cryoablation needles used, freeze and thaw cycles and times, method of thaw and ice formation
  
  
• Hospital Duration [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day ] [ Designated as safety issue: No ]
  Date and time of admission and discharge
  
  
• Difference in average pain scores [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Measured from baseline to within 24 hours of the cryoablation procedure, 1 week, 4 weeks, 8 weeks and 12 weeks as measured on the numeric 0-10 Brief Pain Inventory Scale
  
  
• Percentage of subjects able to reduce analgesic medications [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Measured from baseline to within 24 hours of the cryoablation procedure, 4, 8 and 12 weeks post cryoablation procedure
  
  
• Time to maximal epigastric/abdominal pain relief after cryoablation [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure
  
  
• Time to recurrence of epigastric/abdominal worst pain at or above baseline [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Measured worst pain score in the 12 week follow-up period as measured on a numeric 0-10 Brief Pain Inventory Scale
  
  
• Subject satisfaction with the amount of epigastric/abdominal pain relief from cryoablation procedure [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
  Subjects will answer questions regarding their satisfaction.
  
  
• Safety assessment [ Time Frame: 30 Days post cryoablation ] [ Designated as safety issue: Yes ]
  The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure
  
  

CUC10-PAN09 is a Supportive Care, Phase 1 multicenter, prospective, single arm study with subjects serving as their own control. This study is to enroll patients who will undergo cryoablation of the Celiac Plexus. Subjects will be followed for 3 months post their cryoablation procedure.

Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal) and urology (kidney).