A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Visual Analog Scale Pain Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has Stage IV pancreatic cancer.
- •Patient agrees not to be treated by other oncologists or anesthesiologists during the study.
- •Patient agrees not to obtain pain medications from other physicians during the study.
- •Patient is at least 22 years of age.
- •Investigator considers the patient to be able and willing to fulfill all study requirements.
- •Patient is able to understand the study and provide written informed consent to participate in the study.
排除标准
- •Patient meets any of the contraindications for use of the Prometra Programmable Infusion System (for patients in the ITDD group).
- •Patient is enrolled in another clinical study.
研究组 & 干预措施
Intrathecal Drug Delivery (ITDD)
These subjects will have a Prometra System implanted and managed with the appropriate drug regimen to treat their pain.
干预措施: Intrathecal Drug Delivery System (Device)
Conventional Medical Management (CMM)
These subjects will be treated with conventional medical management to treat their pain.
干预措施: Conventional Medical Management (Other)
结局指标
主要结局
Visual Analog Scale Pain Scores
时间窗: Three months
Level of pain is rated on the visual analog scale. Pain scores after three months of therapy will be compared to baseline pain scores to see if there is a difference.
次要结局
- Survival Rates(Two years)
- Cancer Treatments(Two years)
- Adverse Events(Two years)
- Quality of Life Scores(Two years)
- Hospitalizations and Emergency Room Visits(Two years)