Development and Validation of an Artificial Intelligence-assisted Strategy Selection System for Colonoscopy Cleaning
1 other identifier
observational
657
1 country
1
Brief Summary
Patients with poor inadequate bowel preparation need to undergo secondary colonoscopy. but the evaluation of intestinal cleanliness is judged by doctors subjectively. there are no objective and effective criteria to guide the evaluation. We use the deep learning technique to develop the EndoAngel with real-time intestinal cleanliness assessment. It can derive a decision curve for bowel cleanliness based on the relationship between the percentage of bowel segments with a Boston score of 1 and the adenoma detection rate. It can help doctors to identify patients who need a second colonoscopy, and provide a new way for artificial intelligence in improving the detection rate of colonoscopic adenomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2020
CompletedFirst Submitted
Initial submission to the registry
June 20, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2020
CompletedNovember 17, 2020
November 1, 2020
5 months
June 20, 2020
November 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
The adenoma detection rate (ADR)
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
2020.08.7
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 1 Score
2020.08.7
Secondary Outcomes (12)
The polyp detection rate (PDR)
2020.08.7
The mean number of polyps per patient (MNP)
2020.08.7
The mean number of adenomas per patient (MAP)
2020.08.7
PDR of different sizes
2020.08.7
MNP of different sizes
2020.08.07
- +7 more secondary outcomes
Eligibility Criteria
The primary endpoint was the detection rate of Adenomas and the percentage of 1 score to get a correlation curve. In order to calculate the sample size more accurately, we prepare to collect 200 colonoscopies to explore the sample distribution, and then calculate the sample size according to the sample distribution.
You may qualify if:
- Male or female aged 18 or above;
- Colonoscopy is needed to further clarify the characteristics of digestive tract diseases;
- Patients able to give informed consent were eligible to participate.
- Able and willing to comply with all study process.
- No intestinal organic disease.
You may not qualify if:
- Has participated in other clinical trials, signed informed consent and was in the follow-up period of other clinical trials.
- Has participated in clinical trials of the drug and is in the elution period of the experimental drug or control drug.
- Drug or alcohol abuse or psychological disorder in the last 5 years.
- Patients in pregnancy or lactation.
- Known polyposis syndromes.
- Gastrointestinal Bleeding.
- A history of inflammatory bowel disease, colorectal cancer and colorectal surgery.
- A history of colorectal surgery.
- Patients with a contraindication for biopsy.
- Previous history of allergy to ingredient of bowel cleanser.
- Patients with intestinal obstruction or perforation, toxic megacolon, Colectomy, heart failure (Grade III or IV) , severe cardiovascular disease, severe liver failure or renal insufficiency, etc. .
- Researchers believe that the patient is not suitable to participate in the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin hospital
Wuhan, Hubei, 430000, China
Biospecimen
Patient colonoscopy videos and photodocumentation
Study Officials
- PRINCIPAL INVESTIGATOR
Honggang Yu, Doctor
Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2020
First Posted
June 24, 2020
Study Start
May 11, 2020
Primary Completion
October 15, 2020
Study Completion
November 16, 2020
Last Updated
November 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data disclosure begins 9 months and ends 36 months after article publication.
- Access Criteria
- To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.
Individual de-identified participant data that underlie the results reported in this article and study protocol will be shared for investigators whose proposed use of the data has been approved by an independent review committee. Data can only be used to achieve aims in the approved proposal. Data disclosure begins 9 months and ends 36 months after article publication. To gain access, data requesters will need to sign a data access agreement. Proposals should be directed to the corresponding author.