Clinical trial NCT05909124: MCE for Gastric Examination in Obese People
Official title: A Retrospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Gastric Examination in Obese People
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the degree of gastric mucosal visualization
timeFrame: 2 weeks
Secondary outcomes:
measure: the cleanliness of the stomach
timeFrame: 2 weeks
measure: Stomach transmit time
timeFrame: 2 weeks
measure: Small bowel transmit time
timeFrame: 2 weeks
measure: Incidence of adverse events
timeFrame: 2 weeks
measure: Gastric distention
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Yangyang Qian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.