NCT05013125

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2021

Completed
23 days until next milestone

Study Start

First participant enrolled

August 18, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

July 26, 2021

Last Update Submit

April 25, 2024

Conditions

Colorectal Neoplasms

Keywords

Computer aided Polyp detectionColonoscopyPolyp detectionColorectal polypsColorectal cancer

Outcome Measures

Primary Outcomes (1)

  • Adenoma missed rate

    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 Outcomes (7)

  • Polyp missed rate

    End of study, about 1 year

  • Adenoma detection rate

    End of study, about 1 year

  • Patient missed rate

    End of study, about 1 year

  • Number of polyps removed

    End of study, about 1 year

  • Baseline Parameters

    End of study, about 1 year

  • +2 more secondary outcomes

Study Arms (2)

Conventional Colonoscopy - ENDO-AID assisted Colonoscopy

NO INTERVENTION

Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy

ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy

ACTIVE COMPARATOR

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

Interventions

ENDO-AID CADe assisted ColonoscopyDIAGNOSTIC_TEST

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.

ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Kaori Futaba

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 26, 2021

First Posted

August 19, 2021

Study Start

August 18, 2021

Primary Completion

March 17, 2023

Study Completion

April 30, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations

HK(1)