Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial
The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
Patients undergo NaviEC-2000Pro Gastro Scan mode.
Patients undergo NaviEC-2000Pro Routine gastric examination mode.
Patients undergo NaviEC-1000 Routine gastric examination mode.
the degree of gastric mucosal visualization
The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, \<70% of the gastric mucosa can be observed.
Time frame: 2 weeks
The time of gastric examination
The total time MCE required to complete the stomach examination
Time frame: 2 weeks
detection of lesions
The detection of gastric lesions by MCE
Time frame: 2 weeks
Equipment operation evaluation
Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best
Time frame: 2 weeks
Safety Assessment
Number and incidence of device-related adverse events and serious adverse events
Time frame: 2 weeks
Yangyang Qian
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