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Clinical Trials/NCT06020859
NCT06020859Not yet recruitingNot Applicable

New MCE System for Detection of Gastric Lesions

Changhai Hospital0 sites30 target enrollmentStarted: August 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
the degree of gastric mucosal visualization

Study Overview

Brief Summary

Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial

Detailed Description

The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

the degree of gastric mucosal visualization

Time Frame: 2 weeks

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.

Secondary Outcomes

  • Safety Assessment(2 weeks)
  • detection of lesions(2 weeks)
  • The time of gastric examination(2 weeks)
  • Equipment operation evaluation(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhuan Liao

Professor

Changhai Hospital

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