New MCE System for Detection of Gastric Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Changhai Hospital
- 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
Zhuan Liao
Professor
Changhai Hospital