- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275609
The Efficiency of Writing Endoscopic Reports by Artificial Intelligence and Physicians: a Randomized Controlled Trial
February 18, 2020 updated by: Xiuli Zuo, Shandong University
The purpose of this study is to compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Digestive endoscopy permits early detection of gastrointestinal diseases and improving the patients' quality of life.
However, writing endoscopic report takes a lot of manpower and time, reducing the efficiency of endoscopy.
Our center has developed a structured diagnostic report generation system for digestive endoscopy, which can generates the report by artificial intelligence.
Here, we compare the efficiency of writing endoscopic reports by artificial intelligence and physicians through a randomized controlled trial.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients aged between 18 and 80 years;
- patients undergoing gastroscopy and colonoscopy examination with anesthesia;
- patients able to give informed consent
Exclusion Criteria:
- patients with the contraindications to endoscopic examination;
- a history of gastrointestinal cancers;
- allergic to anaesthetics in previous medical history;
- the endoscopic procedure cannot be completed due to stenosis, obstruction, solid food or complications of anaesthesia.
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Artificial Intelligence generating endoscopic report
In this group, the endoscopic report was generated by artificial intelligence (AI) based on the structured diagnostic report generation system.
|
After the endoscopic procedure, the physicians click the structured reporting button of computer to automatically complete the report through the structured diagnostic report generation system.
The physicians only make minor corrections to the report.
|
Active Comparator: Physicians writing endoscopic report
In this group, the endoscopic report was writing by physicians.
|
After the endoscopic procedure, the physicians writing the report in computer according the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The time spent writing reports
Time Frame: Intraoperative
|
Sum of the time for writing gastroscopic report and colonoscopic report。
|
Intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
February 20, 2020
Primary Completion (Anticipated)
March 20, 2020
Study Completion (Anticipated)
March 30, 2020
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 18, 2020
First Posted (Actual)
February 19, 2020
Study Record Updates
Last Update Posted (Actual)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020SDU-QILU-G002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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