ENDO-AID Assisted Tandem Colonoscopy RCT

April 25, 2024 updated by: Kaori Futaba, Chinese University of Hong Kong

Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial

This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.

A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist.

Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.

Study Type

Interventional

Enrollment (Actual)

360

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 Locations

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Department of Surgery, Chinese University of Hong Kong

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18years or above
  • Referred to endoscopy unit for diagnostic or surveillance colonoscopy

Exclusion Criteria:

  • Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
  • Known history of inflammatory bowel disease
  • Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
  • Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
  • Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
  • Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
  • Patients with known palliative colorectal malignancy
  • Patient with coagulopathy
  • Patient with colostomy
  • Patient with multiple co-morbidities (American Society of Anaesthesiologist >3)
  • Inability to give informed consent

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
No Intervention: Conventional Colonoscopy - ENDO-AID assisted Colonoscopy
Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy
Active Comparator: ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy
Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy
Diagnostic test: ENDO-AID CADe assisted Colonoscopy
ENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma missed rate
Time Frame: End of study, about 1 year
To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.
End of study, about 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp missed rate
Time Frame: End of study, about 1 year
To compare the Polyp missed rate (PMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. PMR is defined as the number of polyps detected in the second pass colonoscopy divided by the total number of polyps detected in both passes for the same patients.
End of study, about 1 year
Adenoma detection rate
Time Frame: End of study, about 1 year
To compare the Adenoma detection rate (ADR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy for the first pass colonoscopy. ADR is defined as the proportion of patients with at least 1 adenoma detected in the first pass colonoscopy.
End of study, about 1 year
Patient missed rate
Time Frame: End of study, about 1 year
To compare the patient missed rate (PMR) between ENDO-AID assisted colonoscopy and conventional white light colonoscopy. PMR is defined as the number of patients in whom adenomas were detected for the first time during second pass colonoscopy divided by the number of patients with at least 1 adenoma detected.
End of study, about 1 year
Number of polyps removed
Time Frame: End of study, about 1 year
To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
End of study, about 1 year
Baseline Parameters
Time Frame: End of study, about 1 year
Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures
End of study, about 1 year
Serious Adverse Events
Time Frame: At 30 days
To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
At 30 days
Number of CAD assisted abnormality
Time Frame: End of study, about 1 year
Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically
End of study, about 1 year

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Kaori Futaba, Chinese University of Hong Kong

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)

August 18, 2021

Primary Completion (Actual)

March 17, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

August 13, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC.2021.336

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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