- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487626
Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring
March 1, 2021 updated by: Dae Kyung Sohn, National Cancer Center, Korea
The purpose of this study is to develop and validate the accuracy and reliability of an artificial intelligence(AI) system for bowel preparation quality scoring based of Boston Bowel preparation Scoring(BBPS).
Then evaluate whether this AI system can help endoscopists to improve the quality of colonoscopy in clinical practice.
Study Overview
Detailed Description
Bowel preparation is one of the most important factors which decide the quality of colonoscopy.
Adequate bowel preparation is essential to guarantee a clear vision of colonic mucosa, complete inspection of entire colon and improves the adenoma detection rates(ADRs).
Therefore, the quality of bowel preparation should be evaluated accurately and objectively.
However, current bowel preparation quality scales depend on memories and subjective decision of endoscopists.
Recently, articifial intelligence system based on deep learning algorithm has been used widely in medical fields.
But, few studies have been reported to evaluate the performance of AI system based on deep learning in bowel preparation quality scoring.
This study aims to develop and train an AI system to assess bowel preparation quality using the BBPS, and validate the AI system to improve the quality of colonoscopy.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- National Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 20-80 years undergoing elective colonoscopy
Exclusion Criteria:
- Patients received colon or rectal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Artificial Intelligence assisted Scoring Group
Patients in this group go through colonoscopy under the AI monitoring device.
|
After taking standard bowel preparation regimen, patients receive colonoscopy under the AI system device.
During the withdrawal phase, bowel preparation quality is assessed by AI-associated scoring system.
The withdrawal time is targeted at least 6min.
Every detected polyp will be removed and obtained for pathological assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
accuracy of bowel preparation score
Time Frame: 6 months
|
Bowel preparation quality was measured by BBPS.
After fully washing or suctioning of colonic contents, three segments including right colon (containing cecum and ascending colon), transvers colon (containing hepatic and splenic flexures) and left colon (containing descending and sigmoid colon) were individually scored from 0 to 3. Point 0 refers to unprepared colon segment with obscured solid stool making mucosa cannot be seen; Point 1 refers to part of mucosa can be seen, but some areas are covered by staining, residual stool, and/or opaque liquid; Point 2 refers to entire mucosa is well-seen; Point 3 refers to clean colon segment without staining, fecal materials or liquids.
A sub-score of each colon segment was used, ranging from minimum 0 to maximum 3. The highest score means the excellent bowel preparation.
Adequate bowel preparation was defined as a total BBPS≥6 and sub-BBPS≥2 per segment.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC2020-0159
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonic Disease
-
Pharmbio Korea Co., Ltd.Not yet recruitingIntestinal Disease | Colonic Disease
-
EP Plus Group Sdn BhdNot yet recruitingGastrointestinal Diseases | Pathologic Processes | Disease | Irritable Bowel Syndrome | Colonic Diseases, Functional | Digestive System Disease | Intestinal Disease | Colonic DiseaseMalaysia
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknownColonic DiseaseItaly
-
Hospital Clinic of BarcelonaMedtronicRecruiting
-
WAE MedicalNot yet recruitingColonic DiseaseUnited States
-
University of AberdeenNHS HighlandNot yet recruiting
-
Beijing Tsinghua Chang Gung HospitalEnrolling by invitation
-
Parc de Salut MarRecruitingAdherence, Patient | Colonic DiseaseSpain
-
Klinikum Hanover-Siloah HospitalUnknownAcute Disease | Diverticulitis, ColonicGermany
-
University Hospital, RouenCompletedFecal Incontinence | Functional Colonic Disease
Clinical Trials on AI
-
Shandong UniversityCompletedArtificial Intelligence | Optical Enhancement Endoscopy | Magnifying EndoscopyChina
-
The University of Hong KongRecruitingColonic Polyp | Colonic Cancer | Colonic AdenomaHong Kong
-
Methinks Software SLNot yet recruitingBrain Ischemia | Stroke, Ischemic | Stroke, Acute | Stroke Hemorrhagic
-
Montreal Heart InstituteNot yet recruiting
-
Kıvanç AkçaHacettepe UniversityCompleted
-
Istituto Clinico HumanitasCompleted
-
Tao OUYANGActive, not recruiting
-
The University of Hong KongOrbisRecruiting
-
Sun Yat-sen UniversityNot yet recruiting
-
Sahlgrenska University Hospital, SwedenRecruiting