NCT03883035

Brief Summary

The aim of our study was to develop an automatic quality-control system and assess the performance of this system in quality control of esophagogastroduodenoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,060

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

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

March 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

March 19, 2019

Last Update Submit

January 28, 2020

Conditions

Esophagogastroduodenoscopy

Keywords

Esophagogastroduodenoscopygastric neoplasmartificial intelligencequality control

Outcome Measures

Primary Outcomes (1)

  • detection rate of gastric neoplasms

    detection rate of gastric neoplasms in different groups

    8 months

Secondary Outcomes (4)

  • mean number of gastric neoplasms detected

    8 months

  • mean inspection completeness

    8 months

  • mean inspection time

    8 months

  • errors of EAS

    8 months

Study Arms (2)

EAS-aided group

EXPERIMENTAL

esophagogastroduodenoscopy examination with the assistance of automatic quality-control system

Other: automatic quality-control system

control group

NO INTERVENTION

conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system

Interventions

automatic quality-control systemOTHER

Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.

EAS-aided group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing EGD examination with anaesthesia;
  • patients able to give informed consent.

You may not qualify if:

  • patients with the contraindications to EGD examination;
  • patients with a prior EGD examination within 1 year before the trial;
  • patients with frankly upper gastrointestinal malignant lesions that were apparent on endoscopy;
  • a history of upper gastrointestinal cancers;
  • allergic to anaesthetic in previous medical history;
  • patients refused to participate in the trial;
  • the EGD procedure cannot be completed due to stenosis, obstruction, solid food, or complications of anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice president of Qilu Hospital

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 20, 2019

Study Start

March 20, 2019

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

CN(1)