Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

May 9, 2023 updated by: E-DA Hospital

Comparison of The Adenoma Detection Rate Between Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision and Standard Colonscopy: A Randomized Controlled Study

Adenoma detection rate (ADR) is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC). Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are promising new devices to improve the ADR. However, the effect of combining AI and Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy examination.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective single-blinded randomized controlled trial of three different types of colonoscopy examinations by 1:1:1 ratio. We use EndoAim AI (ASUS, Taiwan) and Endocuff vision (Olympus, UK) assisted colonoscopy in the first group. We use AI assisted colonoscopy in the 2nd group. We use standard colonoscopy in the 3rd group.

Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screening/surveillance. All endoscopists should receive training on EndoAim AI systems and Endocuff vision. During the procedure, experienced endoscopists use high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) under white light and insert to the cecum in the three different groups. The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice.

The Boston Bowel Preparation Scale is used for grading the bowel preparation quality. The size (compared with biopsy forceps), location and morphology of polyps are recorded by the independent endoscopist. All polyps ae removed by either biopsy or polypectomy. The insertion and withdrawal time are measured. The time of the polypectomy site is not included in the withdrawal time.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Recruiting
        • E-DA Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients over 20 years old are undergoing outpatient sedative colonoscopy in the E-Da Hospital, E-Da cancer Hospital and Chung Shan Medical University Hospital in Taiwan

Exclusion Criteria:

  • A prior history of of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
  • Bleeding tendency
  • For scheduled endoscopic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Artificial Intelligence-assisted Colonoscopy with Endocuff Vision
Use artificial intelligence-assisted colonoscopy with Endocuff Vision
Device: Artificial intelligence
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
Device: Endocuff vision
Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
Device: High-definition endoscope
High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma
Active Comparator: Artificial Intelligence-assisted Colonoscopy
Use artificial intelligence-assisted colonoscopy alone
Device: Artificial intelligence
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
Device: High-definition endoscope
High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma
Sham Comparator: Standard colonoscopy
Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision
Device: High-definition endoscope
High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: One month after colonoscopy
The proportion of patients with at least one adenomas
One month after colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean number of polyp per patient
Time Frame: One month after colonoscopy
The mean number of polyp per patient
One month after colonoscopy
Mean number of adenoma per patient
Time Frame: One month after colonoscopy
The mean number of adenoma per patient
One month after colonoscopy
Polyp detection rate
Time Frame: One month after colonoscopy
The proportion of patients with at least one polyp
One month after colonoscopy
Sessile serrated adenoma detection rate
Time Frame: One month after colonoscopy
The proportion of patients with at least one sessile serrated adenoma
One month after colonoscopy
Sessile serrated polyps detection rate
Time Frame: One month after colonoscopy
The proportion of patients with at least one sessile serrated polyp
One month after colonoscopy
Advanced adenoma detection rate
Time Frame: One month after colonoscopy
The proportion of patients with at least one advanced adenoma
One month after colonoscopy
Total number of polyp or adenoma per patient
Time Frame: One month after colonoscopy
The total number of polyp or adenoma per patient
One month after colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

E-DA Hospital

Collaborators

Chung Shan Medical University

Investigators

  • Study Chair: Ying Nan Tsai, MD, Division of Gastroenterology and Hepatology, E-Da Cancer Hospital, Kaohsiung, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMRP53109N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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