Transitioning to a Valve -Gated Intrathecal Drug Delivery System (IDDS): An Open-Label, Non-Randomized, Single-Blind, Multi-Center, Cross-Over Study (TRANSIT)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduced pain medication through Prometra Implantable Pump System
研究概览
简要总结
Flowonix Prometra® II Programmable Pump may require a smaller dose of drug when converting from other commercially available intrathecal drug delivery systems (IDDS).
详细描述
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.
This study will compare the historical pain medication dose and pain scores using the peristaltic pump at baseline as well as from the last pump refill visit prior to explant to the prospective pain medication dose and pain scores using the valve-gated pump and collected at refill visits 1, 2 and 3 after valve-gated pump implant (but not exceed 12 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This open-label, non-randomized, single-blind, multi-center study is designed to evaluate effects of a planned 20% dose reduction when converting to valve-gated from a peristaltic pump. Study participants will be blinded (single blind) to the dose reduction aspect of this trial and must remain blinded to this dose reduction information throughout the trial in an attempt to provide an unbiased assessment of the pain encountered by the patient with their pain pump medications used.
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female between the ages of 22 and 85 years
- •Be capable of giving informed consent and completing assessments required by the study
- •Have pain intensity of greater than 5 out of 10 as measured by VAS
- •Have an active existing peristaltic intrathecal drug delivery system
- •Have stable drug dosage for at least 6 weeks prior to valve-gated pump implant
- •Be an appropriate candidate for surgery
- •Be able to comply with required study visits and assessments including English proficiency
排除标准
- •Have a significant pain disorder not intended to be treated with the test device or comparator
- •Be terminally ill and/or have a life expectancy of less than 6 months
- •Be a pregnant/lactating woman or a woman of child-bearing potential
- •Have a systemic or local infection (contraindicated for pump implantation)
- •Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
- •Have an underlying condition increasing susceptibility to infection
研究组 & 干预措施
Prometra® Programmable Pump
Pain scores and drug doses will be prospectively collected for valve-gated Prometra® Programmable Pump system(Flowonix Medical)' at (refill #1, refill #2, refill #3) and will be compared to retrospectively collected pain (VAS) scores and drug doses from the last refill prior to peristaltic pump explant.
干预措施: Prometra II Programmable Pump system(Flowonix Medical) (Device)
Prior records for peristaltic pump
Prior pain scores and drug doses from the patients who need a new valve gated pump will be recorded and used for comparison after it is changed.
干预措施: Prometra II Programmable Pump system(Flowonix Medical) (Device)
结局指标
主要结局
Reduced pain medication through Prometra Implantable Pump System
时间窗: 12 months from Implant
Total consumption of Pain medication both oral and intra thecal would also be recorded to show change in pain medication.
次要结局
- Change in pain score: Visual Analog Scale for Pain(12 months from Implant)
研究者
Timothy Lubenow
Director, Pain Center
Rush University Medical Center