NCT03438695Unknown不适用
Total Motorized Spiral Enteroscopy Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Rate of total enteroscopy by Motorized Spiral Enteroscopy
研究概览
简要总结
Study design Prospective bicentric non-controlled clinical trial
Study purpose
- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel
Primary objective
Rate of total enteroscopy by means of NMSE with:
- a complete anterograde approach
- or a combined anterograde and retrograde approach
Secondary objectives
- Procedural success of anterograde and retrograde approach
- Procedural time (minutes)
- Depth of maximum insertion (cm)
- Diagnostic yield
- Therapeutic yield
- Adverse events
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
- •Patients with small bowel disease with an indication for a total enteroscopy, e.g.:
- •Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive Video capsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions
- •Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations
- •Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy
- •Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease
- •Large polyps (>10-15mm) in the jejunum and ileum discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome
- •Nonresponsive or refractory coeliac disease
排除标准
- •- Age under 18 years
- •Health status American Society of Anesthesists Classification (ASA) 4
- •Pregnancy
- •Coagulopathy (INR≥2.0, Platelets < 70/nl)
- •Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days
- •Any medical contraindication to standard enteroscopy
- •Presence of any intraluminal or extraluminal foreign body in the abdominal cavity
- •Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)
- •Known or suspected bowel obstruction or stenosis or history of bowel obstruction
- •Known coagulation disorder
- •Known or suspected esophageal stricture or Schatzki ring
- •Known gastric or esophageal varices
- •Suspected perforation of the GI tract
- •Known or suspected colonic or ileocecal valve (ICV) stricture
- •Inability to tolerate sedation or general anesthesia for any reason
- •Inability to tolerate endotracheal intubation
- •Absence of a signed informed consent
研究组 & 干预措施
Motorized Spiral Enteroscopy
Experimental
Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy
干预措施: Motorized Spiral Enteroscopy (Procedure)
结局指标
主要结局
Rate of total enteroscopy by Motorized Spiral Enteroscopy
时间窗: 2 days
Total enteroscopy by: 1. a complete anterograde approach 2. or a combined anterograde and retrograde approach
次要结局
- Procedural Success Rate(2 days)
- Procedural time(2 days)
- Depth of maximum insertion to the small bowel(2 days)
- Diagnostic yield(2 days)
- Therapeutic yield(2 days)
- Adverse events(3 days)
研究者
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