MCE-new for Detection of Gastric Lesions

Study Overview
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Brief Summary
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Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial

Detailed Description
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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.

Official Title
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New MCE System for Detection of Gastric Lesions

Conditions
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Capsule Endoscopy

Intervention / Treatment
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* Device: undergo NaviEC-2000Pro Gastro Scan mode
* Device: NaviEC-2000Pro Routine gastric examination
* Device: NaviEC-1000 Routine gastric examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: underwent gastric examination; At least 18 years old； Be able to provide informed consent. Exclusion Criteria: With swallowing obstruction or disorders; With known or suspected gastrointestinal obstruction, stenosis and fistula; Have no conditions for surgery or refuse to undergo any abdominal surgery; Be allergic to or have other known contraindication or intolerance to the drug used in the study; With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies; Women during pregnancy; Currently enrolled in another clinical trial of a drug or device; Other conditions determined by the investigator to be inappropriate for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaviEC-2000Pro Gastro Scan<br>NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro | Device: undergo NaviEC-2000Pro Gastro Scan mode<br>* Patients undergo NaviEC-2000Pro Gastro Scan mode.<br>|
| Experimental: NaviEC-2000Pro Routine gastric examination<br>NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro | Device: NaviEC-2000Pro Routine gastric examination<br>* Patients undergo NaviEC-2000Pro Routine gastric examination mode.<br>|
| Active Comparator: NaviEC-1000 Routine gastric examination<br>NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000 | Device: NaviEC-1000 Routine gastric examination<br>* Patients undergo NaviEC-1000 Routine gastric examination mode.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of gastric examination | The total time MCE required to complete the stomach examination | 2 weeks | 
| detection of lesions | The detection of gastric lesions by MCE | 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 | 2 weeks | 
| Safety Assessment | Number and incidence of device-related adverse events and serious adverse events | 2 weeks |