Gastric Electrical Stimulation (GES) for the Treatment of Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- First-in-human experience with the Exilis System, including initial clinical feasibility and safety data, as well as data on device performance (e.g., recharge durations and intervals) and use conditions (e.g., stimulation amplitudes, lead impedances).
研究概览
简要总结
The purpose of this feasibility study is to provide safety data on the implantable Exilis gastric electrical stimulation (GES) system, to individually adjust stimulation parameters to levels that are comfortable for implanted subjects during chronic daily treatment, and to collect data on acute gastrointestinal function and food intake responses to GES during in-clinic testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 21-64 with BMI of 40-45 kg/m^2 or BMI 35-39.9 kg/m^2 with at least one obesity-related comorbidity, who have failed prior non-surgical weight loss attempts, and have been within 5% of their current weight for at least one year.
- •If diabetic, subject has non-insulin-dependent type 2 diabetes mellitus diagnosed within the last 7 years, and has an HbA1c level less than 8%.
- •If female and of child-bearing age, subject is not pregnant or lactating and is willing to use effective contraception for the duration of the study.
- •Subject is willing and able to complete scheduled study visits, complete on-line lifestyle educational modules, and complete required procedures.
排除标准
- •Subject has a history of medical, surgical, or psychiatric conditions that, in the opinion of the Investigators, would limit study participation or contraindicate implantation of the Exilis GES system. Examples includes cardiac abnormalities contraindicating surgical anesthesia, prior gastrointestinal surgery, gastrointestinal motility disorders, inflammatory bowel disease, a history of eating disorders, anticipated future need for magnetic resonance imaging, or allergies to food ingredients in study test meals.
研究组 & 干预措施
Gastric Electrical Stimulation (GES)
Gastric Electrical Stimulation (GES) therapy for the treatment of obesity.
干预措施: Exilis Implantable Gastric Electrical Stimulation (GES) (Device)
结局指标
主要结局
First-in-human experience with the Exilis System, including initial clinical feasibility and safety data, as well as data on device performance (e.g., recharge durations and intervals) and use conditions (e.g., stimulation amplitudes, lead impedances).
时间窗: Duration of study
Once adjudicated by the Adverse Events Advisory Committee (AEAC), all adverse events recorded during the study were tabulated and summarized by seriousness, intensity, and related. Device performance and use conditions where characterized by collecting data on amplitude settings and lead impedance recorded during device interrogations and conducted at each clinic visits. The data will be tabulated and summarized using descriptive statistics, but no hypotheses tests were pre-specified
To gain an understanding of what sensations, if any, subjects feel during GES treatment, and what level and type of sensations subjects find acceptable and comfortable during chronic daily treatment.
时间窗: 4 weeks
In-clinic sensory testing and telephone follow-up were collected during Amplitude Titration phase and will be summarized. No formal hypothesis testing were pre-specified. Fourt separate visits were conducted approximately weekly during the titration phase. The testing procedure was expected to be repeated twice during each visits; once in a fasted state and once in a fed state. Subjects were asked to rate exposure sensitive from 0 (none) to 5 (intense)
次要结局
- Change in gastric emptying time across a pair of in-clinic measurements made with and without GES.(Screening, Week 26 and Week 52)
- Change in whether GES delivered with the Exilis System suppresses post-meal gastric contractile activity(8 and 10 weeks)
- Change in post-meal plasma glucose and insulin concentrations(Baseline and 6 months)
- Changes in coloric intake during a standardized ad libitum solid meal consumed in a controlled setting(8 and 10 weeks)
- Change in physiological parameters, medication usage, and psychometric assessment scores that occur during chronic daily GES treatment with the Exilis System.(Study duration)