AdenomaNCT04453956
A Single Center Study on Comparing the Different Function of EndoAngel in Improving the Quality of Colonscopy
A study testing Colonoscopy with the assistance of EndoAngel's polyp detection function., Colonoscopy with the assistance of EndoAngel's quality monitoring function. and Colonoscopy without the assistance of EndoAngel's any function. in people with Adenoma, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenoma
- What is being tested?
- Colonoscopy with the assistance of EndoAngel's polyp detection function., Colonoscopy with the assistance of EndoAngel's quality monitoring function. and Colonoscopy without the assistance of EndoAngel's any function.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,090 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Oct 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or above;
- Colonoscopy is needed to further characterize gastrointestinal diseases;
- Ability to read, understand and sign informed consent forms;
- The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.
Who cannot join
- Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials；
- Participate in a drug clinical trial and during the elution period of the trial or control drug；
- Drug or alcohol abuse or mental disorder in the last 5 years;
- Pregnant or lactating women;
- Patients with multiple polyp syndrome;
- Patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
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- Patients with known perforation or colonic obstruction;
- Patients with a contraindication for biopsy;
- The researchers did not consider the subjects suitable for colonoscopy;
- The researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Honggang Yu, MD, +8613871281899, yuhonggang1968@163.com
About this study
Official title: A Prospective, Randomized, Single-blind, 2 × 2 Factorial Design Single Center Study Evaluating the Polyp Detection and Quality Monitoring Function of EndoAngel in Improving the Quality of Colonoscopy
An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate.
Read the detailed description
The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. However, the detection rate of adenomatous polyps can vary significantly among endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. The polyp detection function can remind endoscopists of the location of the polyp. The quality monitoring function can monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .
- Conditions
- Adenoma
- Being tested
- Colonoscopy with the assistance of EndoAngel's polyp detection function., Colonoscopy with the assistance of EndoAngel's quality monitoring function., Colonoscopy without the assistance of EndoAngel's any function.
- Keywords
- Polyp Detection, Quality Monitoring, Artificial Intelligence
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with the assistance of EndoAngel's polyp detection function.Diagnostic test
Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
Colonoscopy with the assistance of EndoAngel's quality monitoring function.Diagnostic test
Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
Colonoscopy without the assistance of EndoAngel's any function.Diagnostic test
Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Patients will receive colonoscopy without assistance of EndoAngel's any function. Receives: Diagnostic Test: Colonoscopy without the assistance of EndoAngel's any function. |
| Polyp detection function group | Experimental | Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function. Receives: Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function. |
| Quality monitoring function group | Experimental | Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function. Receives: Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function. |
| Polyp detection plus quality monitoring functions group | Experimental | Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function. Receives: Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function.; Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Measured: 3 Months
Secondary outcomes (12)
Polyp detection rate
The numerator is the number of cases of polyps detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Measured: 3 months
The mean number of polyps per procedure
The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Measured: 3 months
The mean number of adenomas per procedure
The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Measured: 3 months
Detection rate of large, small and diminutive polyps
The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Measured: 3 months
The mean number of large, small and diminutive polyps per procedure
The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) polyps detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Measured: 3 months
Detection rate of large, small and diminutive adenomas
The numerator was the number of patients with large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Measured: 3 months
The mean number of large, small and diminutive adenomas per procedure
The numerator was the number of large (≥10 mm), small (>5 to <10 mm), and diminutive(≤5 mm) adenomas detected by colonoscopy, and the denominator was the total number of patients receiving colonoscopy.
Measured: 3 months
Detection rate of adenoma in different sites
The numerator is the number of cases of adenoma detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Measured: 3 months
The mean number of adenomas in different sites per procedure
The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon and ileocecal region during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Measured: 3 months
Time of colonoscopic insertion
The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening
Measured: 3 months
Time of colonoscopic withdrawal
The duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.
Measured: 3 months
Cecal intubation rate
The numerator is the number of cases of colonoscopy reaching ileocecal valve or appendiceal opening, and the denominator is the total number of colonoscopy cases.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020
- Primary completion20 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenomaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,090 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453956
- Sponsor's protocol ID
- EA-19-001
- Status last verified
- Oct 2020
- First submitted
- 27 Jun 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao L, Zhang L, Liu J, Zhou W, He C, Zhang J, Wu L, Wang H, Xu Y, Gong D, Xu M, Li X, Bai Y, Gong R, Sharma P, Yu H. Effect of an artificial intelligence-based quality improvement system on efficacy of a computer-aided detection system in colonoscopy: a four-group parallel study. Endoscopy. 2022 Aug;54(8):757-768. doi: 10.1055/a-1706-6174. Epub 2022 Feb 4.
PubMed 34823258
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blind, 2 × 2 Factorial Design Single Center Study Evaluating the Polyp Detection and Quality Monitoring Function of EndoAngel in Improving the Quality of Colonoscopy
- ClinicalTrials.gov ID
- NCT04453956
- Acronym / sponsor ID
- EA-19-001
- Conditions
- Adenoma
- Keywords
- Polyp Detection, Quality Monitoring, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,090 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 20 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 1 Jul 2020 (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.
An artificial intelligence-based system, named EndoAngel,has been constructed previously,which has polyp detection and quality monitoring functions. This study aims to evaluate the two different functions of EndoAngle in improving adenoma detection rate.
Detailed description
The detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. However, the detection rate of adenomatous polyps can vary significantly among endoscopists. EndoAngel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. The polyp detection function can remind endoscopists of the location of the polyp. The quality monitoring function can monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.This study aims to evaluate the two different functions of EndoAngle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Diagnostic Test: Colonoscopy without the assistance of EndoAngel's any function.Patients will receive colonoscopy without assistance of EndoAngel's any function. |
| Polyp detection function group | Experimental | Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function.Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection function. |
| Quality monitoring function group | Experimental | Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.Patients will receive colonoscopy with the assistance of EndoAngel's quality monitoring function. |
| Polyp detection plus quality monitoring functions group | Experimental | Diagnostic Test: Colonoscopy with the assistance of EndoAngel's polyp detection function., Diagnostic Test: Colonoscopy with the assistance of EndoAngel's quality monitoring function.Patients will receive colonoscopy with the assistance of EndoAngel's polyp detection plus quality monitoring function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 years or above;
- Colonoscopy is needed to further characterize gastrointestinal diseases;
- Ability to read, understand and sign informed consent forms;
- The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.
Key exclusion criteria (10 listed)
- Participated in other clinical trials, signed informed consent forms and followed up in other clinical trials；
- Participate in a drug clinical trial and during the elution period of the trial or control drug；
- Drug or alcohol abuse or mental disorder in the last 5 years;
- Pregnant or lactating women;
- Patients with multiple polyp syndrome;
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 |
|---|---|---|
| Colonoscopy with the assistance of EndoAngel's polyp detection function.Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp. | Diagnostic test | Polyp detection function group, Polyp detection plus quality monitoring functions group |
| Colonoscopy with the assistance of EndoAngel's quality monitoring function.Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope. | Diagnostic test | Polyp detection plus quality monitoring functions group, Quality monitoring function group |
| Colonoscopy without the assistance of EndoAngel's any function.Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions. | Diagnostic test | Control group |
Primary outcome
Adenoma detection rate
Time frame: 3 Months
The numerator is the number of cases of adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
12 secondary outcomes
Polyp detection rate
Time frame: 3 months
The mean number of polyps per procedure
Time frame: 3 months
The mean number of adenomas per procedure
Time frame: 3 months
Detection rate of large, small and diminutive polyps
Time frame: 3 months
The mean number of large, small and diminutive polyps per procedure
Time frame: 3 months
Detection rate of large, small and diminutive adenomas
Time frame: 3 months
The mean number of large, small and diminutive adenomas per procedure
Time frame: 3 months
Detection rate of adenoma in different sites
Time frame: 3 months
The mean number of adenomas in different sites per procedure
Time frame: 3 months
Time of colonoscopic insertion
Time frame: 3 months
Time of colonoscopic withdrawal
Time frame: 3 months
Cecal intubation rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 34823258Yao L, Zhang L, Liu J, Zhou W, He C, Zhang J, Wu L, Wang H, Xu Y, Gong D, Xu M, Li X, Bai Y, Gong R, Sharma P, Yu H. Effect of an artificial intelligence-based quality improvement system on efficacy of a computer-aided detection system in colonoscopy: a four-group parallel study. Endoscopy. 2022 Aug;54(8):757-768. doi: 10.1055/a-1706-6174. Epub 2022 Feb 4.
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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 Colonoscopy with the assistance of EndoAngel's polyp detection function., Colonoscopy with the assistance of EndoAngel's quality monitoring function. and Colonoscopy without the assistance of EndoAngel's any function. in people with Adenoma, run by Renmin Hospital of Wuhan University at 1 site in China.
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 4 inclusion and 10 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 22 Oct 2020. 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 China. 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. Some participants in this study may receive a placebo. 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 Honggang Yu, MD (+8613871281899, yuhonggang1968@163.com), 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: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04453956, which also lists 1 linked publication.
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 22 Oct 2020.