MCE for Gastric Examination in Obese People

Study Overview
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Brief Summary
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This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people.

Detailed Description
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In this study, we evaluated the feasibility and safety of MCE for the detection of gastric disease in obese people by comparing the results of MCE between healthy weight people (18.5≤BMI<25) and obese people (BMI≥30). The observation index included mucosal visualization, gastric transit time, cleanliness of the stomach, detection of lesions and safety evaluation.

Official Title
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A Retrospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Gastric Examination in Obese People

Conditions
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Obesity

Intervention / Treatment
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* Device: MCE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18.5≤BMI<25 or BMI≥30 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy weight people (18.5≤BMI<25)<br>18.5≤BMI<25 | Device: MCE<br>* underwent MCE examination<br>|
| obese people (BMI≥30)<br>BMI≥30 | Device: MCE<br>* underwent MCE examination<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 cleanliness of the stomach | The criteria for judging the cleanliness of the stomach are: excellent : no adhesive mucus and foam, clear field of view; good : a small amount of mucus and foam, but the field of view is not blurred and does not affect the integrity of the examination; average : medium amount of mucus and foam, the field of view is more blurred and affects the integrity of the examination; poor : a large amount of mucus and foam, the field of view is blurred and affects the integrity of the examination. | 2 weeks | 
| Stomach transmit time | The time of the first stomach image, the first small intestine image and the last image taken by capsule endoscopy were recorded. Stomach transmit time: time of first small intestine image minus time of first stomach image. | 2 weeks | 
| Small bowel transmit time | The time of the first large intestine image minus the time of the first small intestine image. | 2 weeks | 
| Incidence of adverse events | The rates of adverse events such as asphyxia by capsule aspiration, swallow disorder, retention, technical failure, and procedural adverse events were recorded. | 2 weeks | 
| Gastric distention | Assess condition of gastric distention. The criteria for judging gastric distention is: excellent, no obvious gastric folds; good, moderate distance between gastric folds, without folding; fair, short distance between gastric folds, with small amount of folding; poor, no obvious distance between gastric folds, with large amount of folding | 2 weeks |