NCT05909124

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

March 30, 2023

Last Update Submit

June 8, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • the cleanliness of the stomach

    2 weeks

  • Stomach transmit time

    2 weeks

  • Small bowel transmit time

    2 weeks

  • Incidence of adverse events

    2 weeks

  • Gastric distention

    2 weeks

Study Arms (2)

healthy weight people (18.5≤BMI<25)

18.5≤BMI\<25

Device: MCE

obese people (BMI≥30)

BMI≥30

Device: MCE

Interventions

MCEDEVICE

underwent MCE examination

healthy weight people (18.5≤BMI<25)obese people (BMI≥30)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related 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.

    PMID: 23687601BACKGROUND

  • 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.

    PMID: 27211503BACKGROUND

  • 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.

    PMID: 25590177BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yangyang Qian

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Liao

CONTACT

86-21-31161004liaozhuan@smmu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2023

First Posted

June 18, 2023

Study Start

June 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

CN(1)