Pain Management Clinical Trial
Official title:
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with 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.
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