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Trial Title:
Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision
NCT ID:
NCT05863208
Condition:
Adenoma Detection Rate
Conditions: Official terms:
Adenoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Artificial intelligence
Description:
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon
adenoma
Arm group label:
Artificial Intelligence-assisted Colonoscopy
Arm group label:
Artificial Intelligence-assisted Colonoscopy with Endocuff Vision
Intervention type:
Device
Intervention name:
Endocuff vision
Description:
Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
Arm group label:
Artificial Intelligence-assisted Colonoscopy with Endocuff Vision
Intervention type:
Device
Intervention name:
High-definition endoscope
Description:
High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is
used under white light for the detection of colon adenoma
Arm group label:
Artificial Intelligence-assisted Colonoscopy
Arm group label:
Artificial Intelligence-assisted Colonoscopy with Endocuff Vision
Arm group label:
Standard colonoscopy
Summary:
Adenoma detection rate (ADR) is considered the single most important quality measure in
colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC).
Several kinds of new endoscopes and accessories have been accessed to investigate the
abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are
promising new devices to improve the ADR. However, the effect of combining AI and
Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is
to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy
examination.
Detailed description:
This is a prospective single-blinded randomized controlled trial of three different types
of colonoscopy examinations by 1:1:1 ratio. We use EndoAim AI (ASUS, Taiwan) and Endocuff
vision (Olympus, UK) assisted colonoscopy in the first group. We use AI assisted
colonoscopy in the 2nd group. We use standard colonoscopy in the 3rd group.
Eligible patients are older than 40 years old and receive colonoscopy for either
symptomatic or screening/surveillance. All endoscopists should receive training on
EndoAim AI systems and Endocuff vision. During the procedure, experienced endoscopists
use high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Aizu,
Japan) under white light and insert to the cecum in the three different groups. The cecal
intubation is confirmed by the identification of ileocecal valve and appendiceal orifice.
The Boston Bowel Preparation Scale is used for grading the bowel preparation quality. The
size (compared with biopsy forceps), location and morphology of polyps are recorded by
the independent endoscopist. All polyps ae removed by either biopsy or polypectomy. The
insertion and withdrawal time are measured. The time of the polypectomy site is not
included in the withdrawal time.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients over 20 years old are undergoing outpatient sedative colonoscopy in the E-Da
Hospital, E-Da cancer Hospital and Chung Shan Medical University Hospital in Taiwan
Exclusion Criteria:
- A prior history of of inflammatory bowel disease, colorectal cancer, previous bowel
resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis
syndromes
- Bleeding tendency
- For scheduled endoscopic treatment
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
E-DA Hospital
Address:
City:
Kaohsiung City
Zip:
82445
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Ying Nan Tsai, M.D
Phone:
886-7-6150011
Phone ext:
252294
Email:
littlepig9933@gmail.com
Start date:
May 2, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
E-DA Hospital
Agency class:
Other
Collaborator:
Agency:
Chung Shan Medical University
Agency class:
Other
Source:
E-DA Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05863208
