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Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.

Primary Purpose

Colon Adenoma, Colorectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
"aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy
Standard colonoscopy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Adenoma focused on measuring Computer-aided colonoscopy, Artificial intelligence, Colorectal cancer screening

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subjects with any of the following prior history or current conditions:

    1. Contraindications to colonoscopy
    2. Inflammatory bowel disease (IBD)
    3. Colorectal cancer (CRC)
    4. Familial adenomatous polyposis (FAP)
    5. Colonic stenosis
    6. Severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D)
    7. Active gastrointestinal (GI) Bleeding
    8. Pregnancy
    9. Prior colorectal surgery, including colonic or rectal resection (except for appendectomy, surgery on the anus, and polypectomy)
    10. Undergo colonoscopy within 3 years
  • Subjects with any of the following conditions per the investigator's judgement:

    1. High suspicion of IBD, CRC, and FAP.
    2. High risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet medication.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computer-aided colonoscopy

Standard colonoscopy

Arm Description

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.

The subject will receive the standard colonoscopy procedure.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Polyp detection rate (PDR)
Percentage of subjects undergoing a complete colonoscopy who have at least one polyp detected.
Adenomas per colonoscopy (APC)
Number of adenomas per colonoscopy, calculated by dividing the total number of adenomas detected by the total number of colonoscopies.
Polyps per colonoscopy (PPC)
Number of polyps of any kind (i.e., adenoma, sessile serrated polyp, hyperplastic polyp, or non-neoplastic polyp) per colonoscopy, calculated by dividing the total number of polyps detected by the total number of colonoscopies.
Non-neoplastic polypectomy rate (NNPR)
Percentage of subjects with at least one non-neoplastic polypectomy at the time of colonoscopy.
Sessile serrated lesions per colonoscopy (SPC)
Number of sessile serrated lesions (SSLs) per colonoscopy, calculated by dividing the total number of sessile serrated lesions detected by the total number of colonoscopies.
Advanced adenomas per colonoscopy (AAPC)
Number of advanced adenomas per colonoscopy, calculated by dividing the total number of advanced adenomas detected by the total number of colonoscopies.
Withdrawal time
The time spent in inspecting the colonic mucosa as the endoscope is withdrawn during a colonoscopy, excluding procedure time

Full Information

First Posted
February 13, 2022
Last Updated
February 13, 2022
Sponsor
National Taiwan University Hospital
Collaborators
Changhua Christian Hospital, Shin Kong Hospital, Fu Jen Catholic University Hospital, aetherAI Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05240625
Brief Title
Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.
Official Title
Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Changhua Christian Hospital, Shin Kong Hospital, Fu Jen Catholic University Hospital, aetherAI Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This multiple-site study aims to evaluate whether a computer-aided detection (CADe) device can assist in adenoma detection rate (ADR) when compared with the current standard-of-care procedure. The subject CADe device used in this study 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. This study plans to enroll subjects aged ≥ 40 years and < 80 years, who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up. After being evaluated with the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either the computer-aided colonoscopy (CC) or the standard colonoscopy(SC). Randomization will be stratified by gender, age, and colonoscopy indication (screening, diagnostic, or surveillance) of subjects. The resected polyps will be submitted for histologic examination by one expert pathologist at each site. If any uncertainty or doubt exists, an expert in gastrointestinal pathology will serve as the adjudicator to perform a second review and make the final decision. All of the pathologists (including the final adjudicator) who will perform the histopathologic examinations and produce the pathology assessment will be blinded to the assigned study arm of the specimens. The pathology reports of the subjects will be kept securely at each site as the source data. The primary endpoint is the ADR of the CC as compared with that of the SC. The ADR is defined as the percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed. In addition, the following secondary endpoints will also be evaluated, including: Polyp detection rate (PDR), Adenomas per colonoscopy (APC), Polyps per colonoscopy (PPC), Non-neoplastic polypectomy rate (NNPR), Non-neoplastic polypectomy (NNP), Sessile serrated lesions per colonoscopy (SPC), Advanced adenomas per colonoscopy (AAPC), and withdrawal time. Signed written informed consent forms will be obtained from all participating subjects before enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma, Colorectal Cancer
Keywords
Computer-aided colonoscopy, Artificial intelligence, Colorectal cancer screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer-aided colonoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard colonoscopy
Arm Type
Active Comparator
Arm Description
The subject will receive the standard colonoscopy procedure.
Intervention Type
Device
Intervention Name(s)
"aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard colonoscopy
Intervention Description
Standard colonoscopy procedure.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
The percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed.
Time Frame
1 week (after the colonoscopy procedure, when pathology report is released)
Secondary Outcome Measure Information:
Title
Polyp detection rate (PDR)
Description
Percentage of subjects undergoing a complete colonoscopy who have at least one polyp detected.
Time Frame
1 day(right after the colonoscopy procedure)
Title
Adenomas per colonoscopy (APC)
Description
Number of adenomas per colonoscopy, calculated by dividing the total number of adenomas detected by the total number of colonoscopies.
Time Frame
1 week (after the colonoscopy procedure, when pathology report is released)
Title
Polyps per colonoscopy (PPC)
Description
Number of polyps of any kind (i.e., adenoma, sessile serrated polyp, hyperplastic polyp, or non-neoplastic polyp) per colonoscopy, calculated by dividing the total number of polyps detected by the total number of colonoscopies.
Time Frame
1 day(right after the colonoscopy procedure)
Title
Non-neoplastic polypectomy rate (NNPR)
Description
Percentage of subjects with at least one non-neoplastic polypectomy at the time of colonoscopy.
Time Frame
1 week (after the colonoscopy procedure, when pathology report is released)
Title
Sessile serrated lesions per colonoscopy (SPC)
Description
Number of sessile serrated lesions (SSLs) per colonoscopy, calculated by dividing the total number of sessile serrated lesions detected by the total number of colonoscopies.
Time Frame
1 week (after the colonoscopy procedure, when pathology report is released)
Title
Advanced adenomas per colonoscopy (AAPC)
Description
Number of advanced adenomas per colonoscopy, calculated by dividing the total number of advanced adenomas detected by the total number of colonoscopies.
Time Frame
1 week (after the colonoscopy procedure, when pathology report is released)
Title
Withdrawal time
Description
The time spent in inspecting the colonic mucosa as the endoscope is withdrawn during a colonoscopy, excluding procedure time
Time Frame
1 day(right after the colonoscopy procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han-Mo Chiu, MD, PhD
Phone
+886-2-23123456
Ext
65689
Email
hanmochiu@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Chen Lin, MD, MTM, PhD
Phone
+886-2-27856892
Ext
20
Email
pclin@aetherai.com
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei city
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han-Mo Chiu, MD, PhD
Phone
+886-2-2312-3456
Ext
65689
Email
hanmochiu@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not shareable due to local IRB considerations.

Learn more about this trial

Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.

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