Artificial IntelligenceNCT05829590
AI-assisted Colonoscopy Report System In Improving Reporting Quality
A study testing Artificial intelligence assistant system in people with Artificial Intelligence and Colonoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
In this study, the investigators proposed a prospective study about the effectiveness of speech and image recognition-based system in improving reporting quality during colonoscopy for colonoscopy report quality in endoscopists. The participants would be divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence, Colonoscopy
- What is being tested?
- Artificial intelligence assistant system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 31 Jul 2023
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Male or female ≥18 years old;
- Able to read, understand and sign an informed consent;
- The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
- Patients requiring colonoscopy.
- Doctors:
- Males or females who are over 18 years old;
- After qualified medical education and obtaining the Physician's Practice License.
Who cannot join
- Patients:
- Have drug or alcohol abuse or mental disorder in the last 5 years;
- Pregnant or lactating women;
- Patients with known multiple polyp syndrome;
- patients with known inflammatory bowel disease;
- known intestinal stenosis or space-occupying tumor;
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- known colon obstruction or perforation;
- patients with a history of colorectal surgery;
- Patients with a previous history of allergy to pre-used spasmolysis;
- Unable to perform biopsy due to coagulation disorders or oral anticoagulants;
- High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
- Doctors:
- 1. The researcher believes that the subjects are not suitable for participating in clinical trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Speech and Image Recognition Based System in Improving Reporting Quality During Colonoscopy
In this study, the investigators proposed a prospective study about the effectiveness of speech and image recognition-based system in improving reporting quality during colonoscopy for colonoscopy report quality in endoscopists. The participants would be divided into two groups. For the collected colonoscopy videos, group A would record their observations with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions. Group B would complete the endoscopy report without special prompts. After a period of washout period, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the colonoscopy report. Then, the completeness of the colonoscopy report, the completeness of capturing anatomical landmarks and detected lesions, the completeness of structured description, the accuracy of lesion reporting, the time for reporting and the satisfaction with the reporting system are compared with or without AI assistance.
- Conditions
- Artificial Intelligence, Colonoscopy
- Being tested
- Artificial intelligence assistant system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence assistant systemDiagnostic test
The artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions based on speech recognition and deep learning.
| Study group | Role | What they receive |
|---|---|---|
| with Artificial intelligence assistant system | Experimental | Endoscopists would complete the colonoscopy report with the assistance of the artificial intelligence system. Receives: Diagnostic Test: Artificial intelligence assistant system |
| without Artificial intelligence assistant system | No intervention | Endoscopists would complete the colonoscopy report without special prompts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The integrity of colonoscopy report
Report integrity with or without AI-assisted. Calculation method = number of information recorded / total number of information need to record x 100%
Measured: One month
Secondary outcomes (1)
The integrity of capturing anatomical landmarks
The integrity in captured bowel landmrak images with or without AI-assisted. Calculation method = number of anatomical landmarks in captured images / total number of anatomical landmarks x 100%
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 May 2023 (estimated)
- Primary completion15 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05829590
- Sponsor's protocol ID
- EA-23-002
- Status last verified
- Mar 2023
- First submitted
- 2 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech and Image Recognition Based System in Improving Reporting Quality During Colonoscopy
- ClinicalTrials.gov ID
- NCT05829590
- Acronym / sponsor ID
- EA-23-002
- Conditions
- Artificial Intelligence, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
In this study, the investigators proposed a prospective study about the effectiveness of speech and image recognition-based system in improving reporting quality during colonoscopy for colonoscopy report quality in endoscopists. The participants would be divided into two groups. For the collected colonoscopy videos, group A would record their observations with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions. Group B would complete the endoscopy report without special prompts. After a period of washout period, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the colonoscopy report. Then, the completeness of the colonoscopy report, the completeness of capturing anatomical landmarks and detected lesions, the completeness of structured description, the accuracy of lesion reporting, the time for reporting and the satisfaction with the reporting system are compared with or without AI assistance.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with Artificial intelligence assistant system | Experimental | Diagnostic Test: Artificial intelligence assistant systemEndoscopists would complete the colonoscopy report with the assistance of the artificial intelligence system. |
| without Artificial intelligence assistant system | No intervention | –Endoscopists would complete the colonoscopy report without special prompts. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥18 years old;
- Able to read, understand and sign an informed consent;
- The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
- Patients requiring colonoscopy.
- Males or females who are over 18 years old;
Key exclusion criteria (13 listed)
- Have drug or alcohol abuse or mental disorder in the last 5 years;
- Pregnant or lactating women;
- Patients with known multiple polyp syndrome;
- patients with known inflammatory bowel disease;
- known intestinal stenosis or space-occupying tumor;
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 |
|---|---|---|
| Artificial intelligence assistant systemThe artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions based on speech recognition and deep learning. | Diagnostic test | with Artificial intelligence assistant system |
Primary outcome
The integrity of colonoscopy report
Time frame: One month
Report integrity with or without AI-assisted. Calculation method = number of information recorded / total number of information need to record x 100%
1 secondary outcome
The integrity of capturing anatomical landmarks
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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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 Artificial intelligence assistant system in people with Artificial Intelligence and Colonoscopy, 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 8 inclusion and 13 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 25 Apr 2023. 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. 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 (13871281899, yuhonggang1969@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The integrity of colonoscopy report (time frame: One month). 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 25 Apr 2023.