NCT03438695

Total Motorized Spiral Enteroscopy Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Evangelisches Krankenhaus Düsseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Small Bowel Disease

Interventions

Type	Name	Description
PROCEDURE	Motorized Spiral Enteroscopy	Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, After reaching the cecum or if no further advancement of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. If no total enteroscopy was achieved, a submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde peranal enteroscopy is then performed on one of the following days.

Timeline

• Start date: 2018-02-21
• Primary completion: 2019-02-21
• Completion: 2019-02-28
• First posted: 2018-02-20
• Last updated: 2018-02-20