AdenomaNCT04591145
Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System
An observational study of Adenoma and Bowel Preparation, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
A deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase has been constructed previously. This multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adenoma, Bowel Preparation
- What is being tested?
- Observational group
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 31 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Continuous colonoscopy from October to December 2020 will be collected in our participating general hospitals.
Who may be able to join
- Male or female aged 18 years or above;
- 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
- Patients with contraindications to colonoscopy (obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, severe heart failure, etc.);
- Patients with galactosemia;
- Pregnant or lactating women;
- Patients used lactulose, a stimulant, or laxative within 7 days;
- Patients refused to sign informed consent forms.
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: Validation of a Deep Learning Based Bowel Preparation Evaluation System: A Prospective, Multi-center, Cross-sectional Study
A deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase has been constructed previously. This multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion.
Read the detailed description
Inadequate bowel preparation is insufficient for identification of polyps greater than 5 mm. However, bowel preparation assessment involved subjectivity and uncertainty. We constructed a deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase and performed a prospective observational study to validate the threshold of the adequate proportion.The multi-center study is aimed to verify the extrapolation and robustness of the scoring threshold based on artificial intelligence intestinal cleanliness evaluation system explored in the early stage, and propose a more accurate and quantifiable threshold for evaluating the eligibility of intestinal preparation.
- Conditions
- Adenoma, Bowel Preparation
- Being tested
- Observational group
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational groupOther
Patient receive the standard bowel preparation strategy and routine colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Patients received bowel preparation and colonoscopy. The withdrawal phase video was saved and their lesions detection was record. Receives: Other: Observational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleanliness assessment of different intestinal segment in the artificial intelligence system
The Artificial intelligence evaluates the Boston Bowel Preparation score of the ascending colon, transverse colon and descending colon in real-time, and calculates the proportion of 0-1 Score
Measured: 3 Months
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 (10)
Advanced adenoma detection rate
The numerator is the number of cases of advanced adenomas detected by colonoscopy, and the denominator is the total number of cases of patients undergoing colonoscopy.
Measured: 3 Months
Polyps 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 adenomas 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
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/withdrawal
The duration of colonoscopic insertion from rectum to ileocecal valve or appendiceal opening and the duration of colonoscopic withdrawal from ileocecal valve or appendiceal opening to colonoscopy finished.
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 posted19 Oct 2020
- Study start9 Oct 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Hospital of Traditional Chinese Medicine, Wuhan Central Hospital, Wuhan Third Hospital, The General Hospital of Central Theater Command, The Third People's Hospital of Hubei Province, Wuhan Puren Hospital, Wuhan Pu-Ai Hospital, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan Red Cross Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591145
- Sponsor's protocol ID
- EA-20-002
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 19 Oct 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Deep Learning Based Bowel Preparation Evaluation System: A Prospective, Multi-center, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04591145
- Acronym / sponsor ID
- EA-20-002
- Conditions
- Adenoma, Bowel Preparation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Hubei Hospital of Traditional Chinese Medicine, Wuhan Central Hospital, Wuhan Third Hospital, The General Hospital of Central Theater Command, The Third People's Hospital of Hubei Province, Wuhan Puren Hospital, Wuhan Pu-Ai Hospital, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Wuhan Red Cross Hospital
- Study start
- 9 Oct 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Oct 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.
A deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase has been constructed previously. This multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion.
Detailed description
Inadequate bowel preparation is insufficient for identification of polyps greater than 5 mm. However, bowel preparation assessment involved subjectivity and uncertainty. We constructed a deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase and performed a prospective observational study to validate the threshold of the adequate proportion.The multi-center study is aimed to verify the extrapolation and robustness of the scoring threshold based on artificial intelligence intestinal cleanliness evaluation system explored in the early stage, and propose a more accurate and quantifiable threshold for evaluating the eligibility of intestinal preparation.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Observational groupPatients received bowel preparation and colonoscopy. The withdrawal phase video was saved and their lesions detection was record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Continuous colonoscopy from October to December 2020 will be collected in our participating general hospitals.
Key inclusion criteria (3 listed)
- Male or female aged 18 years or above;
- 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 (5 listed)
- Patients with contraindications to colonoscopy (obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, severe heart failure, etc.);
- Patients with galactosemia;
- Pregnant or lactating women;
- Patients used lactulose, a stimulant, or laxative within 7 days;
- Patients refused to sign informed consent forms.
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 |
|---|---|---|
| Observational groupPatient receive the standard bowel preparation strategy and routine colonoscopy | Other | Observational group |
Primary outcome
Cleanliness assessment of different intestinal segment in the artificial intelligence system
Time frame: 3 Months
The Artificial intelligence evaluates the Boston Bowel Preparation score of the ascending colon, transverse colon and descending colon in real-time, and calculates the proportion of 0-1 Score
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.
10 secondary outcomes
Advanced adenoma detection rate
Time frame: 3 Months
Polyps detection rate
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/withdrawal
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 19 Oct 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?
An observational study of Adenoma and Bowel Preparation, 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 3 inclusion and 5 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 19 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. 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?
Cleanliness assessment of different intestinal segment in the artificial intelligence system (time frame: 3 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 19 Oct 2020.