NCT01712087终止不适用
Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity
Codman & Shurtleff2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2012年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
研究概览
简要总结
This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm Scores over the 36-month follow-up period will also be described.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 is a viable candidate for "de novo" or continued (pump replacement) therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by an implantable programmable pump.
- •The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study in accordance with 21 Code of Federal Regulations (CFR) Part
- •The subject is willing to comply with the protocol-specified follow-up visit requirements for a period of 36 months after implant.
- •The subject has an anticipated life expectancy of 24 months or greater.
- •The subject must be 18 years of age or older at time of MedStream implant procedure.
- •The subject is of sufficient body size to accommodate pump placement, in the opinion of the Investigator.
- •The subject will receive a de novo or replacement implant of the MedStream 20 mL or 40 mL pump, MedStream approved catheter(s) and MedStream accessories.
- •The Investigator intends to use Baclofen in the pump for treatment of severe spasticity
- •The subject is capable of self-reporting spasm frequency.
排除标准
- •Concurrent enrollment in an investigational device or drug study that has not completed the required follow-up period.
- •Subject has had an infection and/or inflammation at or near the pump and/or catheter implantation site(s) within 30 days preceding enrollment.
- •Evidence of a fever or infection within 10 days prior to the surgical implant procedure that, in the opinion of the Investigator might impact a successful pump implant.
- •The subject has known hypersensitivity/allergies or contraindication to Baclofen or the materials in the infusion pump or catheter(s).
- •The subject has a co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements or, which might impact the scientific integrity of the study.
- •The subject has a rapid degenerative neurological disease such as lateral sclerosis, amyotrophic lateral sclerosis (ALS), rapidly progressive Multiple Sclerosis, inherited or rapidly progressive leukodystrophies, Moyamoya disease, cerebral autosomal dominant arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL), thrombophilias, rapidly progressive autoimmune disorders, or any disorder where progression of the underlying spinal cord or a central nervous system (CNS) disease is expected to progress significantly over the next 3 years
- •Subject is a prisoner.
- •Subject was previously enrolled in this study.
- •Subject is pregnant or breastfeeding. (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
结局指标
主要结局
The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
时间窗: 24 Months
The primary endpoint is the incidence of MedStream system-related AEs (MedStream pump and catheters) based on Clinical Events Committee determination of relationship, that occur from the start of the MedStream implant procedure (incision) until completion of the 24 month follow-up visit
次要结局
- Procedure-related AEs(24 Months)
- Drug-related AEs associated with other intrathecally-administered medications(24 Months)
- Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.(24 Months)
- MedStream system-related AEs occurring from 24 to 36 months(36 Months)
- Drug-related AEs associated with intrathecal Baclofen(24 Months)
- Disease-related AEs associated with pre-existing conditions(24 Months)
- The secondary effectiveness endpoints will be long-term effectiveness of MedStream System(24 Month)
- Serious Adverse Events (SAEs)(36 Months)
- Unanticipated Adverse Device Effects (UADEs)(24 Months)
研究者
研究点 (2)
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