A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 26
- 主要终点
- Rate of granuloma formation
研究概览
简要总结
The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.
详细描述
This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 meets at least one of the following:
- •is suffering from malignant pain (i.e., cancer pain)
- •has chronic, non-malignant pain
- •subject was enrolled in PUMP I or PUMP II study and chooses to participate in this Post-Approval study
- •Patient with an existing implantable pump for pain therapy that requires replacement
- •Patient is at least 22 years of age.
- •Investigator considers the patient to be able and willing to fulfill all study requirements.
- •Patient has provided written informed consent to participate in the study.
排除标准
- •Patient meets any of the contraindications for use of the Prometra System
- •Patient has a prior history of granuloma formation, or is receiving treatment for a suspected granuloma.
- •Patient is pregnant or breast-feeding or is of child-bearing potential and not employing effective birth control.
研究组 & 干预措施
Prospective pump candidates
New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump
干预措施: Prometra Programmable Intrathecal Infusion Pump (Device)
Previous IDE study subjects continuing with the therapy
Patients who were part of the previous IDE study, still have an active Prometra Programmable Intrathecal Infusion Pump, and are willing to continue in a study protocol.
干预措施: Prometra Programmable Intrathecal Infusion Pump (Device)
结局指标
主要结局
Rate of granuloma formation
时间窗: Five years
The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.
次要结局
- Pump failure(Five years)
- Pump battery life(Five years)