Adenoma Detection Rate Using AI System in China

NCT03840590 | Completed

• 1 other identifier: SINOCOLO2019B
• Study Type: interventional
• Target: 743
• Locations: 1 country
• Sites: 4

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

Conditions

Colorectal Neoplasms; Colonic Polyp; Adenoma

Keywords

adenoma detection rate

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate, ADR

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

  At the end of the procedure, up to 1 hour.

Secondary Outcomes (1)

• Polyp detection rate, PDR

  At the end of the procedure, up to 1 hour.

Study Arms (2)

AI-assisted Colonoscopy

EXPERIMENTAL

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

Device: CSK AI system

Standard Colonoscopy

ACTIVE COMPARATOR

Participants in this arm undergo standard colonoscopy.

Device: Standard Colonoscopy

Interventions

CSK AI system DEVICE

CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.

AI-assisted Colonoscopy

Standard Colonoscopy DEVICE

This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.

Standard Colonoscopy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Tianjin People's Hospital: collaborator
• Tianjin Nankai Hospital: collaborator

Study Sites (4)

Sixth affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, 300100, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• En-Da YU, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: July 10, 2019
• Primary Completion: December 5, 2019
• Study Completion: December 5, 2019
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)