- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05990218
Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Different Operator Experience
December 9, 2024 updated by: Rajavithi Hospital
Efficacy of Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Operators with Different Endoscopic Experience: a Randomized Control Trial
Colonoscopy is the gold standard modality for the detection of colonic polyp.
However, miss polyp occurs especially in right sided colon.
Artificial intelligence (AI) is one of the modality to improve polyp detection but the benefit of AI in operators with different endoscopic experience is still limited.
This study aimed to evaluate the efficacy of AI in the detection of right sided colonic polyp in operators with different endoscopic experience by using double insertion of right side colon, back-to-back basis.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
240
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
-
-
-
Bangkok, Thailand
- Recruiting
- Rajavithi Hospital
-
Contact:
- Tanyaporn Chantarojanasiri, MD
- Phone Number: 0898104033
- Email: chtunya@gmail.com
-
Contact:
- Tanyaporn Chantarojanasiri, MD
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- participants age 40-80 years
Exclusion Criteria:
- History of colonic surgery (except appendectomy)
- Lower gastrointestinal bleeding
- unstable vital sign during endoscopy of pregnancy
- history of inflammatory bowel disease, polyposis syndrome, colon cancer, colonic stricture, abnormal coaglulation, organ failure
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: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control, experienced
Patients received colonoscopy with double insertion of right sided colon under white light by experienced endoscopist
|
The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.
|
|
Active Comparator: control, beginner
Patients received colonoscopy with double insertion of right sided colon under white light by beginner endoscopist
|
The patient received endoscopy under conventional white light for polyp detection during second endoscopic withdrawal.
|
|
Experimental: AI, experience
Patients received colonoscopy with double insertion of right sided colon under AI by experienced endoscopist
|
The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.
|
|
Experimental: AI, beginner
Patients received colonoscopy with double insertion of right sided colon under AI by beginner endoscopist
|
The patient received endoscopy under CADe system for polyp detection during second endoscopic withdrawal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
polyp detection rate
Time Frame: during endoscopy
|
the number of polyp detected during endoscopy
|
during endoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
type of polyp
Time Frame: during endoscopy
|
the type of polyp detected during endoscopy
|
during endoscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
February 13, 2023
Primary Completion (Estimated)
February 12, 2026
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
August 6, 2023
First Submitted That Met QC Criteria
August 6, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Estimated)
December 13, 2024
Last Update Submitted That Met QC Criteria
December 9, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 031/2566
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
product manufactured in and exported from the U.S.
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.
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