Back to resultsArtificial Intelligence in Colonic Polyp Detection
Primary Purpose
Polyp of Colon, Adenoma Colon, Gastrointestinal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Artificial intelligence
No Artificial Intelligence
Sponsored by
About this trial
This is an interventional diagnostic trial for Polyp of Colon focused on measuring colonoscopy, artificial intelligence
Eligibility Criteria
Inclusion Criteria:
- All patients without IBD referred for colonoscopy
Exclusion Criteria:
- Age < 40 years
- Not willing to participate
Sites / Locations
- Dr Per Hedenström
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AI
No AI
Arm Description
Colonoscopy with AI
Colonoscopy without AI
Outcomes
Primary Outcome Measures
ADR
Adenoma detection rate
Secondary Outcome Measures
APC
Adenomas per colonoscopy
Procedural time
The number of minutes required to complete the colonoscopy withdrawal
Full Information
NCT ID
NCT05178095
First Posted
November 15, 2021
Last Updated
June 27, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT05178095
Brief Title
Artificial Intelligence in Colonic Polyp Detection
Official Title
Artificial Intelligence in Colonic Polyp Detection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyp of Colon, Adenoma Colon, Gastrointestinal Neoplasms
Keywords
colonoscopy, artificial intelligence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AI
Arm Type
Experimental
Arm Description
Colonoscopy with AI
Arm Title
No AI
Arm Type
Placebo Comparator
Arm Description
Colonoscopy without AI
Intervention Type
Device
Intervention Name(s)
Artificial intelligence
Intervention Description
Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps
Intervention Type
Device
Intervention Name(s)
No Artificial Intelligence
Intervention Description
Colonoscopy without the aid of artificial intelligence for the detection of colonic polyps
Primary Outcome Measure Information:
Title
ADR
Description
Adenoma detection rate
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
APC
Description
Adenomas per colonoscopy
Time Frame
1 hour
Title
Procedural time
Description
The number of minutes required to complete the colonoscopy withdrawal
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients without IBD referred for colonoscopy
Exclusion Criteria:
Age < 40 years
Not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Lindkvist
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Dr Per Hedenström
City
Gothenburg
ZIP/Postal Code
S-413 45
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Artificial Intelligence in Colonic Polyp Detection
We'll reach out to this number within 24 hrs