NCT01854229已完成不适用
A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 52
- 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.
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)
研究者
研究点 (52)
Loading locations...
相似试验
进行中（未招募）
不适用
The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)ObesityNCT05368259Allurion Technologies1,000
暂停
4 期
TEM-PCR™ Prospective Clinical Utility StudyUpper Resp Tract InfectionNCT04248361Diatherix Laboratories, LLC314
已完成
3 期
Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00097279Novo Nordisk A/S230
招募中
不适用
Comparison of 1 Month vs. 12 Months DAPT in Patients Undergoing PCI With Genoss® DESCoronary Artery DiseaseNCT05770674Kiyuk Chang2,186
招募中
1 期
A Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological MalignanciesNCT06703892GenomeFrontier Therapeutics TW Co., Ltd.18