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Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System

Y

Yanqing Li

Status

Completed

Conditions

Esophagogastroduodenoscopy

Treatments

Other: automatic quality-control system

Study type

Interventional

Funder types

Other

Identifiers

NCT03883035
2019SDU-QILU-02

Details and patient eligibility

About

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.

Full description

In this study, the researchers firstly developed an automatic quality-control system, name as EAS. Next, the researchers applied the system in a endoscopic center and designed a prospective randomised controlled trial to investigate the performance of the system in quality control of esophagogastroduodenoscopy.

Enrollment

1,060 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,060 participants in 2 patient groups

EAS-aided group
Experimental group
Description:
esophagogastroduodenoscopy examination with the assistance of automatic quality-control system
Treatment:
Other: automatic quality-control system
control group
No Intervention group
Description:
conventional standard esophagogastroduodenoscopy examination without the assistance of automatic quality-control system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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