MCE for Gastric Examination in Obese People

June 8, 2023 updated by: Zhuan Liao, Changhai Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

18.5≤BMI<25 or BMI≥30；underwent gastric examination; At least 18 years old；Be able to provide informed consent.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy weight people (18.5≤BMI<25)
18.5≤BMI<25
Device: MCE
underwent MCE examination
obese people (BMI≥30)
BMI≥30
Device: MCE
underwent MCE examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the cleanliness of the stomach
Time Frame: 2 weeks
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
Time Frame: 2 weeks
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
Time Frame: 2 weeks
The time of the first large intestine image minus the time of the first small intestine image.
2 weeks
Incidence of adverse events
Time Frame: 2 weeks
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
Time Frame: 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Yangyang Qian, Changhai hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

June 8, 2023

First Posted (Estimated)

June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MCE for obese people

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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