Computer-aided Detection for Colonoscopy
Computer-aided Detection With Deep Learning for Colorectal Adenoma During Colonoscopic Examination
1 other identifier
interventional
1,000
0 countries
N/A
Brief Summary
We developed an artificial intelligent computer system with a deep neural network to analyze real-time video signals from the endoscopy station. This randomised controlled trial compared adenoma detection rate between computer-assisted colonoscopy and standard colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedFebruary 15, 2019
February 1, 2019
2.8 years
February 13, 2019
February 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
Adenoma detection rate
During colonoscopic examination procedure
Secondary Outcomes (1)
adenomas detected per subject
During colonoscopic examination procedure
Study Arms (2)
Computer-aided detection
EXPERIMENTALStandard colonoscopy
PLACEBO COMPARATORInterventions
We developed an artificial intelligent computer system with a deep neural network (PX-1) to analyze real-time video signals from the endoscopy station
Eligibility Criteria
You may qualify if:
- Patients aged ≥20 years, scheduled for colonoscopy for one of the following indications for colonoscopy, were invited to participate in this study: polyp surveillance, changed bowel habits and/or bloody stools, bowel complaints, a positive family history for CRC, a positive FOBT, abdominal pain, diarrhoea, post-polypectomy surveillance.
You may not qualify if:
- We excluded patients from this study if: (1) they had known colonic neoplasia or inflammatory or other significant colonic disease, such as patients specifically presenting for polypectomy; (2) there was open bleeding or they were receiving an emergency colonoscopy; (3) they had previously previous colonic resection; (4) they were in poor general condition (more than American Society of Anesthesiologists grade III); (5) they were receiving anticoagulant medication; (6) they had severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease); (7) they were not able or refused to give informed written consent; (8) following enrolment and randomisation to one of the arms, those subjects who had inadequate colon preparation or in whom the caecum could not be reached were also excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief
Study Record Dates
First Submitted
February 13, 2019
First Posted
February 15, 2019
Study Start
March 1, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
February 15, 2019
Record last verified: 2019-02