Colon AdenomaNCT05240625
Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.
A study testing "aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy and Standard colonoscopy in people with Colon Adenoma and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Adenoma, Colorectal Cancer
- What is being tested?
- "aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy and Standard colonoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Han-Mo Chiu, MD, PhD, +886-2-2312-3456 ext. 65689, hanmochiu@ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Colon Adenoma, Colorectal Cancer
- Being tested
- "aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy, Standard colonoscopy
- Keywords
- Computer-aided colonoscopy, Artificial intelligence, Colorectal cancer screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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.
Standard colonoscopyProcedure or surgery
Standard colonoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: "aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy; Procedure: Standard colonoscopy |
| Standard colonoscopy | Active comparator | The subject will receive the standard colonoscopy procedure. Receives: Procedure: Standard colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed.
Measured: 1 week (after the colonoscopy procedure, when pathology report is released)
Secondary outcomes (7)
Polyp detection rate (PDR)
Percentage of subjects undergoing a complete colonoscopy who have at least one polyp detected.
Measured: 1 day(right after the colonoscopy procedure)
Adenomas per colonoscopy (APC)
Number of adenomas per colonoscopy, calculated by dividing the total number of adenomas detected by the total number of colonoscopies.
Measured: 1 week (after the colonoscopy procedure, when pathology report is released)
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.
Measured: 1 day(right after the colonoscopy procedure)
Non-neoplastic polypectomy rate (NNPR)
Percentage of subjects with at least one non-neoplastic polypectomy at the time of colonoscopy.
Measured: 1 week (after the colonoscopy procedure, when pathology report is released)
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.
Measured: 1 week (after the colonoscopy procedure, when pathology report is released)
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.
Measured: 1 week (after the colonoscopy procedure, when pathology report is released)
Withdrawal time
The time spent in inspecting the colonic mucosa as the endoscope is withdrawn during a colonoscopy, excluding procedure time
Measured: 1 day(right after the colonoscopy procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhua Christian Hospital, Shin Kong Hospital, Fu Jen Catholic University Hospital, aetherAI Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240625
- Sponsor's protocol ID
- 202112052DIPC
- Status last verified
- Jan 2024
- First submitted
- 13 Feb 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shareable due to local IRB considerations.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.
- ClinicalTrials.gov ID
- NCT05240625
- Acronym / sponsor ID
- 202112052DIPC
- Conditions
- Colon Adenoma, Colorectal Cancer
- Keywords
- Computer-aided colonoscopy, Artificial intelligence, Colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Changhua Christian Hospital, Shin Kong Hospital, Fu Jen Catholic University Hospital, aetherAI Co., Ltd
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-aided colonoscopy | Experimental | Device: "aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy, Procedure: Standard colonoscopyThe 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. |
| Standard colonoscopy | Active comparator | Procedure: Standard colonoscopyThe subject will receive the standard colonoscopy procedure. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Subjects with any of the following prior history or current conditions:
- Subjects with any of the following conditions per the investigator's judgement:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "aetherAI" Computer-aided Polyp Detection (CADe) Systems for ColonoscopyThe 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. | Device | Computer-aided colonoscopy |
| Standard colonoscopyStandard colonoscopy procedure. | Procedure or surgery | Computer-aided colonoscopy, Standard colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: 1 week (after the colonoscopy procedure, when pathology report is released)
The percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed.
7 secondary outcomes
Polyp detection rate (PDR)
Time frame: 1 day(right after the colonoscopy procedure)
Adenomas per colonoscopy (APC)
Time frame: 1 week (after the colonoscopy procedure, when pathology report is released)
Polyps per colonoscopy (PPC)
Time frame: 1 day(right after the colonoscopy procedure)
Non-neoplastic polypectomy rate (NNPR)
Time frame: 1 week (after the colonoscopy procedure, when pathology report is released)
Sessile serrated lesions per colonoscopy (SPC)
Time frame: 1 week (after the colonoscopy procedure, when pathology report is released)
Advanced adenomas per colonoscopy (AAPC)
Time frame: 1 week (after the colonoscopy procedure, when pathology report is released)
Withdrawal time
Time frame: 1 day(right after the colonoscopy procedure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No. Not shareable due to local IRB considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "aetherAI" Computer-aided Polyp Detection (CADe) Systems for Colonoscopy and Standard colonoscopy in people with Colon Adenoma and Colorectal Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-Mo Chiu, MD, PhD (+886-2-23123456 ext. 65689, hanmochiu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 1 week (after the colonoscopy procedure, when pathology report is released)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.