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MCE for Gastric Examination in Obese People

N

Naval Military Medical University

Status

Not yet enrolling

Conditions

Obesity

Treatments

Device: MCE

Study type

Observational

Funder types

Other

Identifiers

NCT05909124
MCE for obese people

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

healthy weight people (18.5≤BMI<25)
Description:
18.5≤BMI\<25
Treatment:
Device: MCE
obese people (BMI≥30)
Description:
BMI≥30
Treatment:
Device: MCE

Trial contacts and locations

1

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Central trial contact

Zhuan Liao

Data sourced from clinicaltrials.gov

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