MCE-new for Detection of Gastric Lesions

August 30, 2023 updated by: Zhuan Liao, Changhai Hospital

New MCE System for Detection of Gastric Lesions

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yangyang Qian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NaviEC-2000Pro Gastro Scan
NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro
Device: undergo NaviEC-2000Pro Gastro Scan mode
Patients undergo NaviEC-2000Pro Gastro Scan mode.
Experimental: NaviEC-2000Pro Routine gastric examination
NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro
Device: NaviEC-2000Pro Routine gastric examination
Patients undergo NaviEC-2000Pro Routine gastric examination mode.
Active Comparator: NaviEC-1000 Routine gastric examination
NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000
Device: NaviEC-1000 Routine gastric examination
Patients undergo NaviEC-1000 Routine gastric examination mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time of gastric examination
Time Frame: 2 weeks
The total time MCE required to complete the stomach examination
2 weeks
detection of lesions
Time Frame: 2 weeks
The detection of gastric lesions by MCE
2 weeks
Equipment operation evaluation
Time Frame: 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
2 weeks
Safety Assessment
Time Frame: 2 weeks
Number and incidence of device-related adverse events and serious adverse events
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MCE-new

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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