NCT05240625

Brief Summary

Colonoscopy is clinically used as the gold standard for detection of colorectal cancer (CRC) and removal of adenomatous polyps of the colon and rectum. Evidence has shown that CRC could be prevented by colonoscopic removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. In recent years, emerging artificial intelligence (AI) and computer-aided detection (CADe) technology has been shown to improve ADR. Based on a meta-analysis, ADR was demonstrated to be significantly higher in the CADe groups than in the standard colonoscopy groups, representing a relative risk of 25.2%. In this study, performance of colonoscopy with or without aid of CADe will be compared in terms of quality indicators. The adenoma detection rate (ADR), which is the proportion of average-risk patients undergoing screening colonoscopy in whom an adenoma is found, is regarded as a robust measure of colonoscopy performance quality that correlates with subsequent cancer risk. Thus, ADR is taken as the primary outcome of this study. The target population includes individuals who are undergoing screening, diagnostic, or surveillance colonoscopy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 20, 2024

Status Verified

January 1, 2024

Enrollment Period

3.8 years

First QC Date

February 13, 2022

Last Update Submit

June 17, 2024

Conditions

Colon AdenomaColorectal Cancer

Keywords

Computer-aided colonoscopyArtificial intelligenceColorectal cancer screening

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    The percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed.

    1 week (after the colonoscopy procedure, when pathology report is released)

Secondary Outcomes (7)

  • Polyp detection rate (PDR)

    1 day(right after the colonoscopy procedure)

  • Adenomas per colonoscopy (APC)

    1 week (after the colonoscopy procedure, when pathology report is released)

  • Polyps per colonoscopy (PPC)

    1 day(right after the colonoscopy procedure)

  • Non-neoplastic polypectomy rate (NNPR)

    1 week (after the colonoscopy procedure, when pathology report is released)

  • Sessile serrated lesions per colonoscopy (SPC)

    1 week (after the colonoscopy procedure, when pathology report is released)

  • +2 more secondary outcomes

Study Arms (2)

Computer-aided colonoscopy

EXPERIMENTAL

The subject will receive the standard colonoscopy procedure simultaneously with a computer-aided detection (CADe) analysis software designed to automatically detect and highlight potential polyps on colonoscopy images in a real-time manner during colonoscopy procedures.

Device: "aetherAI" Computer-aided Polyp Detection (CADe) Systems for ColonoscopyProcedure: Standard colonoscopy

Standard colonoscopy

ACTIVE COMPARATOR

The subject will receive the standard colonoscopy procedure.

Procedure: Standard colonoscopy

Interventions

"aetherAI" Computer-aided Polyp Detection (CADe) Systems for ColonoscopyDEVICE

The investigational medical device is intended to automatically detect potential polyps via colonoscopy in real-time during colonoscopy examinations. The subject device contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic mucosal lesions and the detected polyps will be highlighted to the endoscopists during the real-time colonoscopy procedures.

Computer-aided colonoscopy
Standard colonoscopyPROCEDURE

Standard colonoscopy procedure.

Computer-aided colonoscopyStandard colonoscopy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who have given signed informed consent form
  • Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found
  • Subjects who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up

You may not qualify if:

  • Subjects with any of the following prior history or current conditions:
  • Contraindications to colonoscopy
  • Inflammatory bowel disease (IBD)
  • Colorectal cancer (CRC)
  • Familial adenomatous polyposis (FAP)
  • Colonic stenosis
  • Severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D)
  • Active gastrointestinal (GI) Bleeding
  • Pregnancy
  • Prior colorectal surgery, including colonic or rectal resection (except for appendectomy, surgery on the anus, and polypectomy)
  • Undergo colonoscopy within 3 years
  • Subjects with any of the following conditions per the investigator's judgement:
  • High suspicion of IBD, CRC, and FAP.
  • High risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Drug Delivery SystemsColonoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Han-Mo Chiu, MD, PhD

CONTACT

+886-2-23123456hanmochiu@ntu.edu.tw

Pei-Chen Lin, MD, MTM, PhD

CONTACT

+886-2-27856892pclin@aetherai.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The subject and the pathologist who performs the histopathological review will be blinded to the received procedure, while the operator for colonoscopy will not be blinded to the study arm assigned to the subject.
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2022

First Posted

February 15, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 20, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Not shareable due to local IRB considerations.

Locations

TW(1)