Artificial IntelligenceNCT05718193
Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps
A study testing DeFrame, Classified DeFrame and conventional colonoscopy in people with Artificial Intelligence and Colonoscopy, run by Xiangya Hospital of Central South University at 2 sites in China.
Trial summary
To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Artificial Intelligence, Colonoscopy, Quality Control
- What is being tested?
- DeFrame, Classified DeFrame and conventional colonoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,868 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2022to 15 Mar 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.
Who cannot join
- History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xiangya Hospital Central South University
Changsha, Hunan
Loudi Central Hospital
Loudi, Hunan
About this study
To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.
- Conditions
- Artificial Intelligence, Colonoscopy, Quality Control
- Being tested
- DeFrame, Classified DeFrame, conventional colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeFrameDiagnostic test
The DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion.
Classified DeFrameDiagnostic test
The Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion.
conventional colonoscopyDiagnostic test
conventional colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| The DeFrame Group | Experimental | Subjects in the DeFrame group were treated with a real-time computer-aided polyp detection system named DeFrame during colonoscopy. Receives: Diagnostic Test: DeFrame |
| The Classified DeFrame Group | Experimental | Subjects in the Classified DeFrame group were treated with a real-time computer-aided polyp detection and classification system named Classified DeFrame during colonoscopy. Receives: Diagnostic Test: Classified DeFrame |
| The Control Group | Experimental | Subjects in the control group underwent standard colonoscopy. Receives: Diagnostic Test: conventional colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies.
Measured: up to 9 months
adenomas per colonoscopy
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jun 2022
- Primary completion28 Feb 2023
- Study completion15 Mar 2023
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.
- More trials run by Xiangya Hospital of Central South UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Loudi Central Hospital
- Responsible party
- Sponsor
- Investigators
- xiaowei liu, doctor, Study director, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718193
- Sponsor's protocol ID
- 202112254
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 11 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Artificial Intelligence Assissted Colonoscopy to Identify and Classify Polyps
- ClinicalTrials.gov ID
- NCT05718193
- Acronym / sponsor ID
- 202112254
- Conditions
- Artificial Intelligence, Colonoscopy, Quality Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,868 participants (actual)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Loudi Central Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 8 Feb 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.
To investigate the degree of the real-time detection and classification system for increasing the adenoma detection rate during colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The DeFrame Group | Experimental | Diagnostic Test: DeFrameSubjects in the DeFrame group were treated with a real-time computer-aided polyp detection system named DeFrame during colonoscopy. |
| The Classified DeFrame Group | Experimental | Diagnostic Test: Classified DeFrameSubjects in the Classified DeFrame group were treated with a real-time computer-aided polyp detection and classification system named Classified DeFrame during colonoscopy. |
| The Control Group | Experimental | Diagnostic Test: conventional colonoscopySubjects in the control group underwent standard colonoscopy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 to 85 years old. Colonoscopies for primary CRC screening of the subjects are required.
Key exclusion criteria (1 listed)
- History of CRC,inflammatory bowel disease, previous colonic resection, antithrombotic therapy precluding polyp resection.
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 |
|---|---|---|
| DeFrameThe DeFrame system is applicated during colonoscopy. The DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, notifying the endoscopists of the presence of the lesion. | Diagnostic test | The DeFrame Group |
| Classified DeFrameThe Classified DeFrame system is applicated during colonoscopy. The Classified DeFrame system superimposes a rectangular box on the polyp lesion area in the colonoscopy field of view, the color of the rectangle box will turn blue when the polyp is considered as an adenoma, notifying the endoscopists of the presence of the lesion. | Diagnostic test | The Classified DeFrame Group |
| conventional colonoscopyconventional colonoscopy | Diagnostic test | The Control Group |
Primary outcome
adenoma detection rate
Time frame: up to 9 months
Percentage of patients who have 1 or more histologically confirmed adenoma resected divided by the total number of colonoscopies.
adenomas per colonoscopy
Time frame: up to 9 months
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
xiaowei liu, doctor study director
Xiangya Hospital of Central South University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeFrame, Classified DeFrame and conventional colonoscopy in people with Artificial Intelligence and Colonoscopy, run by Xiangya Hospital of Central South University at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 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 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate (time frame: up to 9 months). The study lists 2 primary outcomes in all. 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 11 Apr 2023.