Safety and Efficacy of Cryoablation for 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).

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