Clinical trial NCT05829590: AI-assisted Colonoscopy Report System In Improving Reporting Quality
Official title: Speech and Image Recognition Based System in Improving Reporting Quality During Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Artificial Intelligence
Colonoscopy
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: In this study, the investigators proposed a prospective study about the effectiveness of speech and image recognition-based system in improving reporting quality during colonoscopy for colonoscopy report quality in endoscopists. The participants would be divided into two groups. For the collected colonoscopy videos, group A would record their observations with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture bowel segment images and prompt abnormal lesions. Group B would complete the endoscopy report without special prompts. After a period of washout period, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the colonoscopy report. Then, the completeness of the colonoscopy report, the completeness of capturing anatomical landmarks and detected lesions, the completeness of structured description, the accuracy of lesion reporting, the time for reporting and the satisfaction with the reporting system are compared with or without AI assistance.


Eligibility criteria: Inclusion Criteria:

Patients:

1. Male or female ≥18 years old;
2. Able to read, understand and sign an informed consent;
3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
4. Patients requiring colonoscopy.

Doctors:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtaining the Physician's Practice License.

Exclusion Criteria:

Patients:

1. Have drug or alcohol abuse or mental disorder in the last 5 years;
2. Pregnant or lactating women;
3. Patients with known multiple polyp syndrome;
4. patients with known inflammatory bowel disease;
5. known intestinal stenosis or space-occupying tumor;
6. known colon obstruction or perforation;
7. patients with a history of colorectal surgery;
8. Patients with a previous history of allergy to pre-used spasmolysis;
9. Unable to perform biopsy due to coagulation disorders or oral anticoagulants;
10. High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Doctors:

1. The researcher believes that the subjects are not suitable for participating in clinical trials.

Primary outcomes:
measure: The integrity of colonoscopy report
timeFrame: One month
Secondary outcomes:
measure: The integrity of capturing anatomical landmarks
timeFrame: One month
Other outcomes:
measure: The integrity of report lesion
timeFrame: One month
measure: The completeness of structured description
timeFrame: One month
measure: Accuracy of lesion reporting
timeFrame: One month
measure: The time for reporting
timeFrame: One month
measure: The satisfaction with the reporting system
timeFrame: One month
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan Univercity
state: Hubei
Study officials:
References: