Observational Registry: The Effectiveness of Pain Management Using the ARCHIMEDES® Implantable Constant-Flow Infusion Pump System for Intrathecal Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Pain management measured by the visual analog pain scale
研究概览
简要总结
The purpose of this observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management
详细描述
Pain management has been a long-standing challenge to the medical community, specifically for the treatment of chronic pain. Chronic Pain is defined by the American Chronic Pain Association as "pain that continues a month or more beyond the usual recovery period for an illness or injury or pain that goes on over months or years as a result of a chronic condition." Chronic pain affects the patient's quality of life, work performance and attendance, mental health, social interactions and overall activities of daily living.
Implantable pumps were used for cancer and non-cancer patients, who had pain, which was resistant to conventional therapy. Intrathecal morphine administration is now accepted as a safe and effective method of controlling or reducing pain and its impact on the sufferer.
The Codman ARCHIMEDES Implantable Constant-Flow Infusion Pump is CE marked, and has been commercially available in Europe for intrathecal delivery of morphine and baclofen since August 1997. ARCHIMEDES is intended for the treatment of chronic intractable (cancer or non-cancer) pain, which requires chronic intrathecal infusion of preservative-free morphine sulfate.
This is a European, multicenter, prospective, single arm, observational registry conducted on a total of 150 Subjects at up to 10 centers in Europe.
Subjects will be followed at 3, 6, 9, and 12 months post Archimedes implant to assess their pain management and quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Subject has been suffering from chronic (benign and/or malignant) intractable pain for at least 2 or more months duration (pending national laws) with a pre-implant value equal or more than 7 on the Visual Analog Pain Scale.
- •The subject does not tolerate oral pain medication at the required therapeutic dose to treat his/her pain.
- •The Subject has a minimum reasonable life expectancy of at least 6 months.
- •The Subject has given written Informed Consent prior to enrollment into this study.
- •The body size of the Subject is sufficient to accept the pump bulk and weight, per the Principal Investigator's discretion.
- •The Subject is willing to participate in this registry for 1 year post implant and is willing to comply with the investigational plan requirements.
- •It is the Principal Investigator's judgment, based on the knowledge of the Subject, and Subject's condition, as well as the features of the implantable system that the Subject is an appropriate candidate for pain management utilizing an implantable pump for continuously delivering preservative-free morphine sulfate via an intrathecal route.
排除标准
- •The Subject has a skin condition (i.e., scleroderma, psoriasis, rash, or open wound) at the site chosen for implantation that would compromise the integrity or access to the injection port.
- •The Subject has previously enrolled in or participated in an investigational drug or device trial within the preceding 4 weeks.
- •The Subject has any known contraindication to preservative-free morphine sulfate.
- •The Subject has a suspected or documented allergy to preservative-free morphine sulfate or related drugs.
- •The Subject has a suspected or documented allergy to the materials of the infusion pump or catheter(s) (for example, silicone).
- •The Subject has a history of drug and/or alcohol abuse per Principal Investigator discretion.
- •The Subject is a female who is pregnant or lactating.
结局指标
主要结局
Pain management measured by the visual analog pain scale
时间窗: Quarterly for 1 year post-implant
Pain management measured by quality of life score (SF-36)
时间窗: Quarterly for 1 year post-implant
次要结局
- Device-related adverse events over the duration of the study(End of trial)