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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Galil Medical
Sponsor:
Information provided by (Responsible Party):
Galil Medical
ClinicalTrials.gov Identifier:
NCT01335945
First received: April 13, 2011
Last updated: July 11, 2014
Last verified: July 2014

April 13, 2011
July 11, 2014
August 2011
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01335945 on ClinicalTrials.gov Archive Site
  • 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
  • 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: Procedure Day (day 1) ] [ 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 (day 1 until dishcarge) ] [ 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
Not Provided
Not Provided
 
Safety and Efficacy of Cryoablation for Abdominal Pain Associated With Pancreatic Cancer
Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated With Pancreatic Cancer

CUC10-PAN09 will evaluate the safety and efficacy of cryoablation therapy on the relief of epigastric/abdominal pain associated with pancreatic cancer.

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).

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Pain
  • Pancreatic Cancer
Procedure: Cryoablation
All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
Other Names:
  • Cryotherapy
  • Visual-ICE cryoablation system
  • SeedNet cryoablation system
  • PresIce cryoablation system
  • IceRod cryoablation needles
  • IceRod PLUS cryoablation needles
  • IceRod CX cryoablation needles
  • IceEDGE 2.4 cryoablation needles
  • IceSphere cryoablation needles
  • IceSeed cryoablation needles
Cryoablation
Freezing of the celiac plexus
Intervention: Procedure: Cryoablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be at least 18 years old
  • Subject has unresectable or inoperable pancreatic carcinoma as determined by CT or MRI
  • Subject's epigastric/abdominal 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) on the BPI despite pharmaceutical pain management
  • ECOG of 0-3
  • Platelet count >50,000
  • INR <1.5

Exclusion Criteria:

  • Subject's life expectancy is <3 months
  • Subject has current neutropenia (ANC <1000)
  • Subject unable to undergo CT or MRI
  • Subject had previous ETOH neurolytic block for pancreatic cancer-related pain less than 2 weeks from screening
  • Subject had surgery <4 weeks from screening
Both
18 Years and older
No
Contact: Maria Plentl, MSN 651-287-5057 Maria.Plentl@galilmedical.com
United States
 
NCT01335945
CUC10-PAN09
No
Galil Medical
Galil Medical
Not Provided
Principal Investigator: David D Childs, MD
Galil Medical
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP