Feasibility and Safety of PillBot™ - Remotely Controlled Capsule Endoscopy: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The PillBot System is an endoscopic capsule imaging system intended for visualization of the stomach. In contrast to currently used passive capsule endoscopy systems, and FDA cleared active magnetic system, the PillBot System uses active, motorized propulsion technology to facilitate the navigation and positioning of the capsule within the stomach anatomy for imaging of the gastric mucosa by an operator
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Age ≥ 18 years
- •Ability to provide written, informed consent to undergo both capsule endoscopy (un-sedated) and conventional OGD
- •Willing and able to complete study follow-up requirements
- •Patient has appropriate indications for upper endoscopy including symptoms of, but not limited to upper abdominal pain, acid reflux, heartburn, iron deficiency anemia, weight loss, bloating, belching, nausea, vomiting and atypical chest pain
排除标准
- •All patients who meet any of the following criteria should not be enrolled into the study:
- •Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000
- •Active bleeding
- •Need for therapeutic procedures during endoscopy
- •Lactation
- •Dysphagia, or other swallowing disorders
- •Known esophageal diverticulum or stricture
- •Swallowing disorder
- •Known luminal, gastrointestinal strictures
- •Patient with Crohn's disease or other potential obstructive conditions, unless there is a recent Computed tomography enterography (CTE) or Magnetic resonance enterography (MRE), MRE or patency capsule performed to exclude an obstructive lesion that may retain the capsule
- •History of esophageal, gastric surgery or intestinal surgery
- •Esophageal or GI motility disorder
- •Known or suspected gastrointestinal obstruction, significant intestinal strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- •Current participation in another investigational drug or device treatment study
- •Pregnant or wishes to become pregnant during the study follow-up period
- •Patient with implanted medical device that would be potentially affected radiofrequency emissions (e.g., pacemakers, implanted cardiac defibrillators)
- •Severe psychiatric, neurological, cardio-vascular, or renal disorders
- •History of allergy or intolerance to materials used to make the PillBot
研究组 & 干预措施
PillBot
Patient will swallow the PillBot and be assessed with EGD after two hours of the examination
干预措施: PillBot (Device)
结局指标
主要结局
Primary Safety Endpoint
时间窗: Up to two weeks
Adverse events rate during and following device use.
Primary Effectiveness Endpoint
时间窗: Through study completion, an average of two weeks
Identification of the gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus) with PillBot compared to conventional endoscopy.
次要结局
- Secondary Study Endpoints(Through study completion, an average of two weeks)