Colonic PolypNCT04485715
Application of AI in Polypectomy
A study testing AI system in people with Colonic Polyp, run by Yanqing Li at 1 site in China.
Trial summary
The aim of this study was to assess the performance of AI system in polypectomy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- AI system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2020to 21 Sep 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to undergo colorectal polypectomy;
- agree to give written informed consent
Who cannot join
- patients with the contraindications to colorectal polypectomy;
- patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
- patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
- patients refused to participate in the trial;
- the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
- the procedure have to be terminated due to complications of anaesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong
Yanqing Li, PhD, MD, 86-531-82166095, liyanqing@sdu.edu.cn
About this study
Official title: Application of Artificial Intelligence in Colorectal Polypectomy
The aim of this study was to assess the performance of AI system in polypectomy
- Conditions
- Colonic Polyp
- Being tested
- AI system
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI systemOther
The real-time assistance of AI system
| Study group | Role | What they receive |
|---|---|---|
| AI-aided group | Experimental | Not described Receives: Other: AI system |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
polypectomy time
the time for detection in polypectomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start21 Jul 2020 (estimated)
- Primary completion21 Jul 2021 (estimated)
- Study completion21 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqing Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485715
- Sponsor's protocol ID
- 2020SDU-QILU-0714
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Artificial Intelligence in Colorectal Polypectomy
- ClinicalTrials.gov ID
- NCT04485715
- Acronym / sponsor ID
- 2020SDU-QILU-0714
- Conditions
- Colonic Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yanqing LiUniversity, hospital or other
- Study start
- 21 Jul 2020 (estimated)
- Primary completion
- 21 Jul 2021 (estimated)
- Study completion
- 21 Sep 2021 (estimated)
- First posted
- 24 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.
The aim of this study was to assess the performance of AI system in polypectomy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-aided group | Experimental | Other: AI system |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to undergo colorectal polypectomy;
- agree to give written informed consent
Key exclusion criteria (6 listed)
- patients with the contraindications to colorectal polypectomy;
- patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
- patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
- patients refused to participate in the trial;
- the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
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 |
|---|---|---|
| AI systemThe real-time assistance of AI system | Other | AI-aided group |
Primary outcome
polypectomy time
Time frame: 12 months
the time for detection in polypectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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 AI system in people with Colonic Polyp, run by Yanqing Li 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 2 inclusion and 6 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 24 Jul 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. 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 Yanqing Li, PhD, MD (86-531-82166095, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polypectomy time (time frame: 12 months). 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 24 Jul 2020.