MCE for Gastric Examination in Obese People

NCT ID: NCT05909124

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2023-10-31

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.

Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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healthy weight people (18.5≤BMI<25)

18.5≤BMI\<25

MCE

Intervention Type DEVICE

underwent MCE examination

obese people (BMI≥30)

BMI≥30

MCE

Intervention Type DEVICE

underwent MCE examination

Interventions

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MCE

underwent MCE examination

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Liao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yangyang Qian

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Zhuan Liao

Role: CONTACT

86-21-31161004

References

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Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.

Reference Type BACKGROUND
PMID: 23687601 (View on PubMed)

Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.

Reference Type BACKGROUND
PMID: 27211503 (View on PubMed)

Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.

Reference Type BACKGROUND
PMID: 25590177 (View on PubMed)

Other Identifiers

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MCE for obese people

Identifier Type: -

Identifier Source: org_study_id

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