Basic Assessment of Safety and Minimally Invasive Stimulation Via Injectrode
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis
研究概览
简要总结
The objectives of this non-significant risk (NSR) study are to evaluate the safety of the short term placement of the Basmati Injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate subcutaneous nerves on the explant date just prior to explant.
详细描述
This was a prospective, single-center, single-arm, non-randomized study design. A sample of 10 study participants were enrolled into the study, and provided with the placement of a Basmati Injectrode insert with a maximal placement duration of up to 28 days. Subjects who were selected to participate in the trial were healthy volunteers adults with ages 18 years and older without any preexisting condition indicated for treatment. Each subject was followed during the trial period of approximately 45+/-2 days.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) and understand the study requirements.
- •Be 18 years of age or older when written informed consent is obtained.
- •Be in good physical and mental health as assessed by a general practitioner.
- •Be able to tolerate electrical stimulation (TENS).
- •Be willing and able to understand and comply with all study-related procedures during the course of the study.
排除标准
- •Have a cognitive impairment or exhibit any characteristic that would limit the study candidate's ability to completely understand and sign a valid, IRB-approved informed consent form.
- •Have a positive pregnancy test (conducted during enrollment).
- •Have a positive Allergic reactivity to Gold skin test (conducted during enrollment).
- •Show symptoms indicative for Covid19 as assessed during enrollment.
- •Have a skin condition at the planned surgical location.
- •Have a blood coagulation disorder or other indication with the potential to impact the study biocompatibility data in unpredictable ways.
- •Have a medical condition that is a contraindication for minimally invasive surgery.
- •Be implanted with a cardiac defibrillator or pump.
- •Have a history of cardiac arrhythmia with hemodynamic instability
- •Be implanted with a neurostimulator.
- •Have any active electrical implant of any other kind.
- •Have metal implants (particularly in hip).
- •Have active infection.
- •Have allodynia.
- •Take regular use of antiplatelet medications (e.g. aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat) or eptifibatide (Integrilin)).
- •Have untreated drug habituation or dependence.
- •Have uncontrolled seizures (averaging > 2 seizures per month).
- •Currently require, or be likely to require, diathermy and/or MRI during study duration.
- •Have a history of adverse reactions to local anesthetics (e.g. lidocaine).
结局指标
主要结局
Safety - Number of Participants With Device-Related Adverse Events & Histological Analysis
时间窗: 28 days
Primary measures of device safety included verification of the absence of unexpected inflammation and minimization of excessive encapsulation around the Injectrode as verified by cell staining and pathohistological analysis.
次要结局
未报告次要终点