Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Performance comparison (frequency) between Gastric Alimetry and predicate device
研究概览
简要总结
Clinical evaluation to compare performance of the physiological recordings from the Gastric Alimetry System vs a predicate reference device (Medtronic Polygram NET / Polygraf ID EGG System
详细描述
A prospective, non-randomised, single centre investigation on patients with suspected motility disorders comprising a simultaneous head-to-head comparison of device performance between the Gastric Alimetry System and the Medtronic Polygram NET / Polygraf ID EGG System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 years old or older
- •Able to provide written informed consent
- •Patients with a suspected motility disorder, meetingRome IVCriteria for functional dyspepsia or chronic nausea and vomiting syndromes or having a diagnosis of gastroparesis as confirmed by a standardized gastric scintigraphy study, including having >10% gastric meal retention at 4-hours.
排除标准
- •BMI >35 kg m(2)
- •Known metabolic, neurogenic or endocrine disorders known to cause gastrointestinal dysmotility e.g. multiple sclerosis, Parkinson's disease, hypothyroidism
- •Known current gastrointestinal infection (includes H.pylori when being actively treated)
- •Known current inflammatory bowel disease
- •Known current gastrointestinal malignancy
- •Previous gastroduodenal surgery
- •Open abdominal wounds or abdominal skin not intact (e.g.rash, abrasions, weeping tissues)
- •Fragile skin evidenced by high susceptibility to skin tears or skin that bruises easily
- •Regular cannabis use
- •Allergy to adhesives
- •Pregnancy
结局指标
主要结局
Performance comparison (frequency) between Gastric Alimetry and predicate device
时间窗: 90 minutes
Mean frequency of raw data from predicate device compared with the same measure from the Gastric Alimetry System. Electrode placement is identical and recording is simultaneous.
次要结局
- Performance comparison (amplitude) between Gastric Alimetry and predicate device(90 minutes)
- Performance comparison (amplitude) between Gastric Alimetry (4 channels as per Primary Outcome Measure) and Gastric Alimetry (8 highest amplitude electrodes).(90 minutes)
- Safety Endpoint(Five hours)
- User Needs Endpoint(Five hours)
研究者
Greg O'Grady
Professor
University of Auckland, New Zealand