MCE for Gastric Examination in Obese People

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05909124
• Other study ID #: MCE for obese people
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: October 2023

Study information

• Verified date: June 2023
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Phone: 86-21-31161004
• Email: liaozhuan[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• MCE
underwent MCE examination

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree of gastric mucosal visualization	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	the cleanliness of the stomach	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
Secondary	Stomach transmit time	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
Secondary	Small bowel transmit time	The time of the first large intestine image minus the time of the first small intestine image.	2 weeks
Secondary	Incidence of adverse events	The rates of adverse events such as asphyxia by capsule aspiration, swallow disorder, retention, technical failure, and procedural adverse events were recorded.	2 weeks
Secondary	Gastric distention	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