Small Bowel Disease Clinical Trial
Official title:
Total Motorized Spiral Enteroscopy Trial
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:
1. a complete anterograde approach
2. 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
n/a
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