NCT04278196

Brief Summary

During the past several years，MCE（magnet controlled endoscopy）has made great process in detecting lesions of gastric as well as screening. Compared with conventional endoscopy, magnetically controlled capsule endoscopy can be further optimized in gastric examination. So we make an AI for operators to help improve the quality of MCE and record the mucosa visibilty of gastirc.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

February 19, 2020

Last Update Submit

May 7, 2021

Conditions

Magnet Controlled Capsule Endoscopy

Keywords

Artificial intelligenceMagnet controlled capsule endoscopy

Outcome Measures

Primary Outcomes (3)

  • The integrity of the magnet controlled capsule endoscopy

    The performance of the operator developing the MCE in screen the gastric without omissions

    2 months

  • The visibilty of the gastric

    Evaluating the performance of AI to recognize the visibility of gastric mucosa

    2 months

  • The time of operation in gastric

    Calculating the time of the magnet controlled capsule endoscapy

    2 months

Interventions

AI-BoxOTHER

AI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled .

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who acccept the magnet controlled capsule endoscopy with the help of "AI-box"will be enrolled.

You may qualify if:

  • patients between 18 and75
  • patients who can sign informed consent

You may not qualify if:

  • patients who are unsuitable to accept the check

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Qilu Hospital

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 20, 2020

Study Start

January 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 30, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

CN(1)