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Outcome Measures

Primary Outcomes (1)

Mean inspection completeness
After the inspection，investigators will review the whole process of inspection and record the sites observed as well as unobserved sites，then calculate the inspection completeness（number of observed sites in each patient/10）besides the the blind spot rate(number of unobserved sites in each patient/10 ) per procedure in control group and AI-assisted group.
4 months

Secondary Outcomes (1)

Cleanliness judgement consistency between expert and AI-box
4 months

Study Arms (2)

Participates being subjected to capsule endoscopy (AI-box assistant)

EXPERIMENTAL

In this group ,Participates will be subjected to magnetically controlled capsule gastroscopy with AI-box assistant.

Other: AI-box

Participates being subjected to capsule endoscopy

NO INTERVENTION

In this group ,Participates will be subjected to magnetically controlled capsule gastroscopy without AI-box assistant.

Interventions

AI-boxOther

Automatic quality-control system（AI-box）could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness.

Participates being subjected to capsule endoscopy (AI-box assistant)

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Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Consecutive patients aged 18-75 years old who underwent MCCG examination in Qilu Hospital of Shandong University, Shandong Provincial Hospital affilated to Shandong First Medican University, and the Binzhou Medical University Hospital.

You may not qualify if:

Related Publications (1)

Wang X, Shen D, Zhao Y, Xing J, Liu J, Zhou R, Yang C, Liu C, Ma X, Ge J, Zhang H, Yuan W, Zhang H, Ma Y, Hu P, Zuo X, Li Y, Li Z. Impact of a real-time automatic quality control system for magnetically controlled capsule gastroscopy: a multicenter randomized controlled trial. BMC Med. 2026 May 2;24(1):369. doi: 10.1186/s12916-026-04901-0.

PMID: 42069608DERIVED

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, OUTCOMES ASSESSOR

Masking Details

Both participates and outcomes Assesors will be masked

Purpose

SCREENING

Intervention Model

PARALLEL

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Vice President of Qilu Hospital

A Real-time Quality Control System of Magnetic-controlled Capsule Gastroscopy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Participates being subjected to capsule endoscopy (AI-box assistant)

Participates being subjected to capsule endoscopy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Participates being subjected to capsule endoscopy (AI-box assistant)

Participates being subjected to capsule endoscopy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations