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Adenoma Detection Rate Using AI System in China (SinoAIADR)

Primary Purpose

Colorectal Neoplasms, Colonic Polyp, Adenoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CSK AI system
Standard Colonoscopy
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring adenoma detection rate

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients referred for screening, surveillance, or diagnostic colonoscopy
  • All patients must be able to give informed consent

Exclusion Criteria:

  • Patients with any absolute contraindications to colonoscopy
  • Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
  • Patients with known colon cancer or polyposis syndromes
  • Patients with known colonic strictures
  • Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
  • Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  • Patients lacking capacity to give informed consent
  • Pregnancy
  • Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
  • Patients who are attending for a therapeutic procedure or assessment of a known lesion

Sites / Locations

  • Sixth affiliated Hospital, Sun Yat-Sen University
  • Shanghai Zhongshan Hospital
  • Tianjin Nankai Hospital
  • Tianjin People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AI-assisted Colonoscopy

Standard Colonoscopy

Arm Description

Participants in this arm undergo AI-assisted colonoscopy using CSK AI system.

Participants in this arm undergo standard colonoscopy.

Outcomes

Primary Outcome Measures

Adenoma detection rate, ADR
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.

Secondary Outcome Measures

Polyp detection rate, PDR
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.

Full Information

First Posted
February 12, 2019
Last Updated
September 24, 2020
Sponsor
Changhai Hospital
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University, Shanghai Zhongshan Hospital, Tianjin People's Hospital, Tianjin Nankai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03840590
Brief Title
Adenoma Detection Rate Using AI System in China
Acronym
SinoAIADR
Official Title
Adenoma Detection Rate Using Artificial Intelligence System in China
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2019 (Actual)
Primary Completion Date
December 5, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University, Shanghai Zhongshan Hospital, Tianjin People's Hospital, Tianjin Nankai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is - to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence is used. Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Detailed Description
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates". A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there is a significant improvement in detection of adenomas when the system is used. This study will randomize patients coming for colonoscopy to have their procedure performed as usual or as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 4 centers, recruiting a total of 800 participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Colonic Polyp, Adenoma
Keywords
adenoma detection rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
743 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AI-assisted Colonoscopy
Arm Type
Experimental
Arm Description
Participants in this arm undergo AI-assisted colonoscopy using CSK AI system.
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Participants in this arm undergo standard colonoscopy.
Intervention Type
Device
Intervention Name(s)
CSK AI system
Intervention Description
CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.
Primary Outcome Measure Information:
Title
Adenoma detection rate, ADR
Description
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
Time Frame
At the end of the procedure, up to 1 hour.
Secondary Outcome Measure Information:
Title
Polyp detection rate, PDR
Description
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
Time Frame
At the end of the procedure, up to 1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients referred for screening, surveillance, or diagnostic colonoscopy All patients must be able to give informed consent Exclusion Criteria: Patients with any absolute contraindications to colonoscopy Patients with established or suspicion of large bowel obstruction or pseudo-obstruction Patients with known colon cancer or polyposis syndromes Patients with known colonic strictures Patients with known severe diverticular segments (that is likely to impede colonoscope passage) Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) Patients lacking capacity to give informed consent Pregnancy Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure. Patients who are attending for a therapeutic procedure or assessment of a known lesion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
En-Da YU, MD
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sixth affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Tianjin Nankai Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300100
Country
China
Facility Name
Tianjin People's Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300121
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Adenoma Detection Rate Using AI System in China

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