A Retrospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Gastric Examination in Obese People
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Changhai Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- the degree of gastric mucosal visualization
Study Overview
Brief Summary
This retrospective study aimed to evaluate the feasibility and safety of MCE for the detection of gastric disease in obese people.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
the degree of gastric mucosal visualization
Time Frame: 2 weeks
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.
Secondary Outcomes
- the cleanliness of the stomach(2 weeks)
- Gastric distention(2 weeks)
- Stomach transmit time(2 weeks)
- Incidence of adverse events(2 weeks)
- Small bowel transmit time(2 weeks)
Investigators
Zhuan Liao
Professor
Changhai Hospital