Clinical trial NCT04437615: Colorectal Polyp Clinical Decision Support Device Study
Official title: Evaluation of the Clinical Performance of an Investigational Real-Time Colorectal Polyp Clinical Decision Support Device (CDSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Polyp
Colorectal
Colonoscopy
Keywords: Colon
Polyp
Colorectal
Colonoscopy
AI
Narrow Band Imaging
Polyp Prediction
Artificial Intelligence
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 2379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study shall be a prospective, single arm, multicenter study.
Primary purpose: OTHER

Brief summary: The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.

Detailed description: Prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience.

Consecutive consented patients meeting the entrance criteria will undergo standard colonoscopy with the adjunctive use of CDSD. Sensitivity and specificity of CDSD-unaided and CDSD-aided predictions will be compared with the ground truth of histopathology.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Willing and able to provide informed consent
* Subjects undergoing colonoscopy

Exclusion Criteria:

* Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
* Inflammatory Bowel Disease
* Hereditary Non Polyposis Colorectal Cancer
* Severe coagulopathy
* Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.
* No diminutive polyps detected during colonoscopy

Primary outcomes:
measure: Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
timeFrame: Upon receipt of pathology results (within one week)
Secondary outcomes:
measure: 1. Number of Unaided NBI Prediction and Pathology Result of Diminutive Polyps Detected by the Endoscopist and Confirmed by Pathology for Which CDSD Does Not Return a Prediction.
timeFrame: Upon receipt of pathology results (within one week)
measure: 2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.
timeFrame: Upon receipt of pathology results (within one week)
measure: 3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.
timeFrame: Upon receipt of pathology results (within one week)
measure: 4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
timeFrame: Upon receipt of pathology results (within one week)
measure: 5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.
timeFrame: Upon receipt of pathology results (within one week)
measure: 6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD
timeFrame: Upon receipt of pathology results (within one week)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Borland Groover
state: Florida
Study officials:
References: