A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis Using an Active Implantable Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Safety and tolerability of the Galvani system
研究概览
简要总结
This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.
详细描述
The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult-onset RA of at least six months duration
- •Male or female participants, 22-75 years of age
- •Active RA
- •Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis)
- •Have an appropriate washout from previously used biological DMARDs or JAKi
- •A female participant should have no child-bearing potential
排除标准
- •Inability to provide informed consent.
- •Significant psychiatric disease or substance abuse.
- •History of unilateral or bilateral vagotomy.
- •Active or latent tuberculosis
- •Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B.
- •Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
- •Previous splenectomy
- •Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
- •Uncontrolled other inflammatory diseases
- •Current/recurrent infections that in the opinion of the PI risk>benefit.
- •History of cancer within the past 5 years, except non-malignant skin cancer.
- •Chronic use of morphine or oxicodone
结局指标
主要结局
Safety and tolerability of the Galvani system
时间窗: 12 weeks
Incidence and relatedness of Adverse Events (AEs), which include clinically significant findings from Laboratory Safety Assessments (clinical chemistry and hematology), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and 12-Lead ECG
次要结局
- To evaluate the usability of the external Galvani System devices and accessories(12 weeks)
- Effect of stimulation on the change in pharmacodynamic and response biomarkers(Day 1 to week 12)
- To evaluate the participants' perception of therapy and sensation(12 weeks)
- Evaluate device performance(12 weeks)