N/A N=2,379 Other

Colorectal Polyp Clinical Decision Support Device Study

Polyp · Colorectal · Colonoscopy

Bottom Line

View on ClinicalTrials.gov: NCT04437615 ↗

Enrolled (actual)

2,379

Serious AEs

—

Results posted

Apr 2025

Primary outcome: Primary: Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology — 90.8; 90.7; 64.7; 59.5 percentage of polyps

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Colonoscopy (Procedure); Clinical Decision Support Device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Olympus Corporation of the Americas
Primary completion: Sep 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology	90.8; 90.7; 64.7; 59.5	—
SECONDARY 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.	112	—
SECONDARY 2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.	88.5; 61.1; 74.7; 80.4	—
SECONDARY 3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.	90.7; 59.5; 74.6; 83.8	—
SECONDARY 4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.	86.5; 69.5; 78.6; 79.9	—
SECONDARY 5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.	90.8; 64.7; 76.8; 85.0	—
SECONDARY 6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD	251	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04437615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.