NCT05435872

Brief Summary

Study objective: To establish a quality control system for gastrointestinal endoscopy based on artificial intelligence technology and an auxiliary diagnosis system that can perform lesion identification, improving the detection rate of early gastrointestinal cancer while standardizing, normalizing, and homogenizing the endoscopic treatment in primary hospitals (including some of the primary hospitals, which are participating in Beijing-Tianjin-Hebei Gastrointestinal Endoscopy Medical Consortium) under Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform as the hardware base. Study design: This study is a prospective, multi-center, real-world study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

July 9, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

June 23, 2022

Last Update Submit

July 8, 2022

Conditions

Diagnoses DiseaseQuality ControlEndoscopyArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Diagnosis rate of early gastrointestinal cancer.

    The number of patients diagnosed with early gastrointestinal cancer is divided by the total number of patients undergoing digestive endoscopy of the intervention group with Artificial Intelligence Cloud Platform Auxiliary and the control group with nothing. The Early Gastrointestinal cancer in this study is defined as ① early gastric cancer and ② progressive adenoma of the colon and serrated adenoma. The pathology of biopsies will be referred to the official report of the pathologists in the participating centers, which shall be filled in and uploaded to the cloud platform.

    two years

Secondary Outcomes (2)

  • Indicators for Quality Control of gastroscopy

    two years

  • Indicators for Quality Control of colonoscopy

    two years

Study Arms (2)

The intervention group (Artificial intelligence Cloud Platform Auxiliary Group)

EXPERIMENTAL

The patients in this group would be examined by endoscopists with the Artificial intelligence Cloud Platform Auxiliary Device launched with gastrointestinal endoscopy.

Device: The Artificial intelligence Cloud Platform

The control group (Non-Auxiliary Group).

NO INTERVENTION

The patients in this group would be examined by endoscopists with the gastrointestinal endoscopy alone.

Interventions

The Artificial intelligence Cloud PlatformDEVICE

The Artificial intelligence Cloud Platform would be used as the auxiliary device for endoscopists during the whole endoscopic examination to help endoscopists complete the quality control, indicate potential lesions, and aid in diagnosis.

The intervention group (Artificial intelligence Cloud Platform Auxiliary Group)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • From the beginning to the end of the study, patients who received gastroscopy and colonoscopy due to confirmed clinical indications were admitted to Beijing Aerospace General Hospital, Beijing Fangshan District Liangxiang Hospital, People's Hospital of Beijing Daxing District, Gucheng Country Hospital of Hebei Province, and Nanhe Country Hospital of Hebei Province.
  • After fully informing and answering the questions, the endoscopic examination with Gastrointestinal Endoscopy Artificial Intelligence Cloud Platform can be accepted, and a signed informed consent form can be provided.

You may not qualify if:

  • Patients who refuse to participate in this study;
  • Patients with intolerance or contraindications to endoscopic examination, such as severe cardiopulmonary diseases, coagulation disorders, or a total of platelet less than 50\*10\^9/L.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Study Officials

  • Aiming Yang, M.D.

    Peking Union Medical College Hospital

    STUDY DIRECTOR

  • Shengyu Zhang

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengyu Zhang, M.D.

CONTACT

+8618501155701pumchzsy@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

July 9, 2022

Primary Completion

February 1, 2024

Study Completion

July 1, 2024

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

CN(1)