N/A
Completed N=2,379
Colorectal Polyp Clinical Decision Support Device Study
Polyp · Colorectal · Colonoscopy
Source: ClinicalTrials.gov NCT04437615 ↗
Enrolled (actual)
2,379
Serious AEs
—
Results posted
Apr 2025
Primary outcomePrimary: 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
Summary
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
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 | — |
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
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. Informational only — not medical advice.