MCE-new for Detection of Gastric Lesions

Not Applicable

Not yet recruiting

• Conditions: Capsule Endoscopy
• Interventions: Device: NaviEC-2000Pro Routine gastric examination; Device: undergo NaviEC-2000Pro Gastro Scan mode; Device: NaviEC-1000 Routine gastric examination

• Registration Number: NCT06020859
• Lead Sponsor: Changhai Hospital

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 Timeline

• Study First Submitted: 2023-07-25
• Status Verified: 2023-08
• Study Start: 2023-08-30
• Study First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaviEC-2000Pro Routine gastric examination	NaviEC-2000Pro Routine gastric examination	NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro
NaviEC-2000Pro Gastro Scan	undergo NaviEC-2000Pro Gastro Scan mode	NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro
NaviEC-1000 Routine gastric examination	NaviEC-1000 Routine gastric examination	NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000

Primary Outcome Measures

Name	Time	Method
the degree of gastric mucosal visualization	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 Outcome Measures

Name	Time	Method
Safety Assessment	2 weeks	Number and incidence of device-related adverse events and serious adverse events
detection of lesions	2 weeks	The detection of gastric lesions by MCE
The time of gastric examination	2 weeks	The total time MCE required to complete the stomach examination
Equipment operation evaluation	2 weeks	Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best