Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization.
研究概览
简要总结
To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.
详细描述
Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.
The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid™ BGE device in the examination of the small intestine in conjunction with a standard endoscope.
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Female aged between 18-80 years (inclusive).
- •Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
- •Symptomatic subject defined as having at least one of the following signs or symptoms:
- •Abdominal pain
- •Unexplained Anemia
- •GI bleeding from an unknown source
- •Small bowel abnormality on any imaging study
- •Subject able to comprehend and give informed consent for participation in this study
- •Signed Informed Consent Form
排除标准
- •Pregnancy
- •Acute bowel obstruction
- •Concomitant Coumadin or warfarin use
- •Severe diverticulitis
- •Recent (within the last 3 months) coronary ischemia or CVA (stroke)
- •Any chronic unstable disease
- •Bleeding disorders
- •Needing emergency surgery
- •Any patient condition deemed too risky for SBE by the investigator
- •Known cognitive or psychiatric disorder
- •Physician objection
- •Concurrent participation in any other clinical trial
结局指标
主要结局
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization.
时间窗: Within 6 months of completion of the trial
次要结局
- Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure.(Within 6 months of completion of the trial)