ColonoscopyNCT05444166
Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the ADR
An observational study of Colonoscopy and Artificial Intelligence, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Artificial Intelligence, Gastrointestinal Disease
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2022to 29 Nov 2023
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: In this study, endoscopists who completed at least 140 colonoscopies were selected as the research objects, and patients who met the criteria were included in the experiment.
Who may be able to join
- 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 screening colonoscopy.
Who cannot join
- 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;
- known colon obstruction or perforation;
Show all 10Show fewer
- patients with a history of colorectal surgery;
- Patients with a previous history of allergy to pre-used spasmolysis;
- Unable to perform biopsy and polyp removal 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital
Hubei, Wuhan, Hubei, 430000
Honggang Yu, Doctor, 8613871281899, yuhonggang@whu.edu.cn
Chaijie Luo, Doctor, 8619828616210, 937648081@qq.com
About this study
Official title: Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the Adenoma Detection Rate: a Prospective, Multicenter, Observational Study
In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it based on optical flow method and the adenoma detection rate.
Read the detailed description
Study showed that adequate withdrawal time is an important prerequisite for full mucosal inspection. In a large population-based analysis, a 1-min increase in withdrawal time led to a 3.6% increase in the ADR. Protocols or expert consensus recommend a standard withdrawal time of 6 min or longer. However, Findings of studies showed that a number of colonoscopies had a withdrawal time less than 6 min, which greatly reduces the ADR.
Investigator's preliminary experiments have shown that deep learning can monitor the colonoscopy withdrawal time in real-time and improve the adenoma detection rate. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy withdrawal assessment system.
The investigators improved EndoAngel to use optical flow method to monitor the colonoscopy withdrawal speed. The performance of the EndoAngel system was verified in colonoscopy videos. The investigators then aimed to evaluate whether the EndoAngel system could improve polyp detection rate after restricting the colonoscopy withdrawal speed.
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The adenoma detection rate (ADR)
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
Measured: A month
The percentage of colonoscopy withdrawal overspeed
The percentage of colonoscopy withdrawal overspeed was calculated by dividing the time of colonoscopy withdrawal overspeed by the total time of colonoscopy withdrawal.
Measured: A month
Secondary outcomes (5)
The polyp detection rate (PDR)
PDR was calculated by dividing the total number of patients being detected polyps by the number of colonoscopies.
Measured: A month
The mean number of polyps per patient (MNP)
MNP was calculated by dividing the total number of polyps by the number of colonoscopies.
Measured: A month
The mean number of adenomas per patient (MAP)
MAP was calculated by dividing the total number of adenomas by the number of colonoscopies.
Measured: A month
colonoscopy withdrawal time
The time is taken to finish the examination from the beginning of the ileocecal region.
Measured: A month
colonoscopy forward time
The time is taken to go from the rectum to the ileocecal region.
Measured: A month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start29 Jul 2022
- Primary completion29 Oct 2023 (estimated)
- Study completion29 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 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
- NCT05444166
- Sponsor's protocol ID
- EA-22-020
- Status last verified
- Mar 2023
- First submitted
- 29 Jun 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the Adenoma Detection Rate: a Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT05444166
- Acronym / sponsor ID
- EA-22-020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 29 Oct 2023 (estimated)
- Study completion
- 29 Nov 2023 (estimated)
- First posted
- 5 Jul 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.
In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it based on optical flow method and the adenoma detection rate.
Detailed description
Study showed that adequate withdrawal time is an important prerequisite for full mucosal inspection. In a large population-based analysis, a 1-min increase in withdrawal time led to a 3.6% increase in the ADR. Protocols or expert consensus recommend a standard withdrawal time of 6 min or longer. However, Findings of studies showed that a number of colonoscopies had a withdrawal time less than 6 min, which greatly reduces the ADR.
Investigator's preliminary experiments have shown that deep learning can monitor the colonoscopy withdrawal time in real-time and improve the adenoma detection rate. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy withdrawal assessment system.
The investigators improved EndoAngel to use optical flow method to monitor the colonoscopy withdrawal speed. The performance of the EndoAngel system was verified in colonoscopy videos. The investigators then aimed to evaluate whether the EndoAngel system could improve polyp detection rate after restricting the colonoscopy withdrawal speed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, endoscopists who completed at least 140 colonoscopies were selected as the research objects, and patients who met the criteria were included in the experiment.
Key inclusion criteria (4 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 screening colonoscopy.
Key exclusion criteria (10 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.
Primary outcome
The adenoma detection rate (ADR)
Time frame: A month
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
The percentage of colonoscopy withdrawal overspeed
Time frame: A month
The percentage of colonoscopy withdrawal overspeed was calculated by dividing the time of colonoscopy withdrawal overspeed by the total time of colonoscopy withdrawal.
5 secondary outcomes
The polyp detection rate (PDR)
Time frame: A month
The mean number of polyps per patient (MNP)
Time frame: A month
The mean number of adenomas per patient (MAP)
Time frame: A month
colonoscopy withdrawal time
Time frame: A month
colonoscopy forward time
Time frame: A month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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?
An observational study of Colonoscopy and Artificial Intelligence, 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 29 Mar 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, Doctor (8613871281899, yuhonggang@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adenoma detection rate (ADR) (time frame: A month). 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 29 Mar 2023.