Back to resultsSurveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE) (SMARTIE)
Primary Purpose
Surveillance Endoscopy for Colorectal Cancer, Artificial Intelligence, Polyps of Colon
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ENDOMIND
Sponsored by
About this trial
This is an interventional diagnostic trial for Surveillance Endoscopy for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- indication CRC surveillance endoscopy
- indication post-polypectomy surveillance endoscopy
- positive fecal immunochemical test in patients >=50 years
Exclusion Criteria:
- reasonable suspicion of inflammatory bowl disease
- reasonable suspicion of familiar polyposis Syndrome
- Patient after radiation/resection of colonic parts
Sites / Locations
- Universitätsklinikum Würzburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
surveillance endoscopy with CADe support
conventional surveillance endoscopy
Arm Description
Endoscopy perfomed with CADe support.
Endoscopy perfomed without CADe support.
Outcomes
Primary Outcome Measures
adenoma detection rate
proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas
Secondary Outcome Measures
polyp detection rate
Exmainations with minimum one polyp detected.
withdrawal time
Time of withdrawal.
resection time
Time spent on polyp resections.
Boston Bowl Preparation Score
minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance
Full Information
NCT ID
NCT05006092
First Posted
June 11, 2021
Last Updated
April 26, 2023
Sponsor
Wuerzburg University Hospital
Collaborators
Klinikum Stuttgart
1. Study Identification
Unique Protocol Identification Number
NCT05006092
Brief Title
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)
Acronym
SMARTIE
Official Title
Multicenter Evaluation Study of the CADe System ENDOMIND in Surveillance Endoscopy for Colorectal Cancer in German Outpatient Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
Klinikum Stuttgart
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
Evaluation of an artificial intelligence system for polyp detection (CADe)
Detailed Description
We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surveillance Endoscopy for Colorectal Cancer, Artificial Intelligence, Polyps of Colon, CADe
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surveillance endoscopy with CADe support
Arm Type
Experimental
Arm Description
Endoscopy perfomed with CADe support.
Arm Title
conventional surveillance endoscopy
Arm Type
No Intervention
Arm Description
Endoscopy perfomed without CADe support.
Intervention Type
Device
Intervention Name(s)
ENDOMIND
Intervention Description
CADe system for Polyp detection
Primary Outcome Measure Information:
Title
adenoma detection rate
Description
proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas
Time Frame
4 months
Secondary Outcome Measure Information:
Title
polyp detection rate
Description
Exmainations with minimum one polyp detected.
Time Frame
4 months
Title
withdrawal time
Description
Time of withdrawal.
Time Frame
4 months
Title
resection time
Description
Time spent on polyp resections.
Time Frame
4 months
Title
Boston Bowl Preparation Score
Description
minimum 0, Maximum 9; should be higher than 5 for appropriate surveillance
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
indication CRC surveillance endoscopy
indication post-polypectomy surveillance endoscopy
positive fecal immunochemical test in patients >=50 years
Exclusion Criteria:
reasonable suspicion of inflammatory bowl disease
reasonable suspicion of familiar polyposis Syndrome
Patient after radiation/resection of colonic parts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Hann
Organizational Affiliation
Wuerzburg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35543874
Citation
Lux TJ, Banck M, Sassmannshausen Z, Troya J, Krenzer A, Fitting D, Sudarevic B, Zoller WG, Puppe F, Meining A, Hann A. Pilot study of a new freely available computer-aided polyp detection system in clinical practice. Int J Colorectal Dis. 2022 Jun;37(6):1349-1354. doi: 10.1007/s00384-022-04178-8. Epub 2022 May 11.
Results Reference
derived
Learn more about this trial
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)
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