Back to resultsComputer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
Primary Purpose
Colon Polyp
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Computer-aided diagnosis
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Polyp
Eligibility Criteria
Inclusion Criteria:
the same as colonoscopy
Exclusion Criteria:
the same as colonoscopy
Sites / Locations
- Endoscopy Center, Tri-Service General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Computer-aided diagnosis
traditional diagnosis
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity, Specificity, False Positive, False Negative
Diagnostic accuracy
Secondary Outcome Measures
Full Information
NCT ID
NCT03069833
First Posted
February 28, 2017
Last Updated
March 25, 2017
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03069833
Brief Title
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
Official Title
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
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
An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Computer-aided diagnosis
Arm Type
Experimental
Arm Title
traditional diagnosis
Arm Type
No Intervention
Intervention Type
Diagnostic Test
Intervention Name(s)
Computer-aided diagnosis
Intervention Description
computer-aided diagnosis to assist colonoscopists
Primary Outcome Measure Information:
Title
Sensitivity, Specificity, False Positive, False Negative
Description
Diagnostic accuracy
Time Frame
Duration between endoscopic diagnosis and pathologic diagnosis is about one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
the same as colonoscopy
Exclusion Criteria:
the same as colonoscopy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng-Jen Chen, MD
Phone
+886-87923311
Ext
88056
Email
endoscopy@ndmctsgh.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng-Jen Chen, MD
Organizational Affiliation
Tri-Service General Hospital, National Defense Medical Center, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng-Jen Chen, MD
Phone
+886-87923311
Ext
88056
Email
endoscopy@ndmctsgh.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
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