NCT04954677

Brief Summary

With the rapid development of artificial intelligence technology, more and more deep learning technology has been applied to medicine. Our research is to develop a set of quality control system for magnetic capsule gastroscope using deep learning technology, and conduct a randomized controlled trial to verify its practical efficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

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

First Submitted

Initial submission to the registry

June 18, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 27, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

January 3, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

June 18, 2021

Last Update Submit

January 2, 2025

Conditions

Magnet Controlled Capsule Endoscopy

Keywords

Artificial intelligenceDeep learning

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)

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:

  • People who are allergic to the ingredients prepared in the stomach before examination;
  • Patients with astrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
  • Patients with esophageal and gastric tumor diseases that are undergoing active surgical treatment;
  • Contraindications to the MCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc; presence of gastrointestinal obstruction symptoms such as pain or dysphagia;
  • Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
  • Inoperative conditions or refusal to undergo abdominal surgery if required (ie, if the capsule will not pass and cannot be removed by endoscopy);
  • A cardiac pacemaker is installed in the body, except when the pacemaker is a new MRE-compatible product;
  • Electronic devices such as cochlear implant, magnetic metal drug infusion pump, nerve stimulator and magnetic metal foreign body are implanted in vivo;
  • Planned MRI examination before capsule endoscopy discharge;
  • Pregnant women;
  • Patients with deglutition disorders or gastric emptizing disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Study Officials

  • Yanqing Li, PhD

    Qilu Hospital of Shandong University

    STUDY CHAIR

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

Study Record Dates

First Submitted

June 18, 2021

First Posted

July 8, 2021

Study Start

August 27, 2021

Primary Completion

July 28, 2022

Study Completion

August 4, 2022

Last Updated

January 3, 2025

Record last verified: 2025-01

Locations

CN(1)