Back to resultsApplication of AI in Polypectomy
Primary Purpose
Colonic Polyp
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AI system
Sponsored by
About this trial
This is an interventional other trial for Colonic Polyp
Eligibility Criteria
Inclusion Criteria:
- to undergo colorectal polypectomy;
- agree to give written informed consent
Exclusion Criteria:
- patients with the contraindications to colorectal polypectomy;
- patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
- patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
- patients refused to participate in the trial;
- the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
- the procedure have to be terminated due to complications of anaesthesia.
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
AI-aided group
control group
Arm Description
Outcomes
Primary Outcome Measures
polypectomy time
the time for detection in polypectomy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04485715
Brief Title
Application of AI in Polypectomy
Official Title
Application of Artificial Intelligence in Colorectal Polypectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2020 (Anticipated)
Primary Completion Date
July 21, 2021 (Anticipated)
Study Completion Date
September 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqing Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to assess the performance of AI system in polypectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AI-aided group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
AI system
Intervention Description
The real-time assistance of AI system
Primary Outcome Measure Information:
Title
polypectomy time
Description
the time for detection in polypectomy
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
to undergo colorectal polypectomy;
agree to give written informed consent
Exclusion Criteria:
patients with the contraindications to colorectal polypectomy;
patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
patients refused to participate in the trial;
the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
the procedure have to be terminated due to complications of anaesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqing Li, PhD, MD
Phone
86-531-82166095
Email
liyanqing@sdu.edu.cn
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD, MD
Phone
86-531-82166095
Email
liyanqing@sdu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Application of AI in Polypectomy
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