A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain

This study is a non-randomized, open-label, single-center study that will compare efficacy of
pain treatment with ITDD to efficacy of pain treatment with CMM in patients suffering from
pancreatic cancer pain.

There will be two treatment groups: Study group (ITDD): These subjects will have a Prometra
System implanted and managed with the appropriate drug regimen to treat their pain. Systemic
analgesics will not be prescribed for this group. Control group (CMM): These subjects will be
treated with CMM to treat their pain.

A maximum of 30 subjects (maximum of 15 in each treatment group) may be enrolled in this
study at one study center.

Inclusion Criteria:

1. Patient has Stage IV pancreatic cancer.

2. Patient agrees not to be treated by other oncologists or anesthesiologists during the
study.

3. Patient agrees not to obtain pain medications from other physicians during the study.

4. Patient is at least 22 years of age.

5. Investigator considers the patient to be able and willing to fulfill all study
requirements.

6. Patient is able to understand the study and provide written informed consent to
participate in the study.

Exclusion Criteria:

1. Patient meets any of the contraindications for use of the Prometra Programmable
Infusion System (for patients in the ITDD group).

2. Patient is enrolled in another clinical study.