Trial Outcomes & Findings for Colorectal Polyp Clinical Decision Support Device Study (NCT NCT04437615)
NCT ID: NCT04437615
Last Updated: 2025-04-17
Results Overview
CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results.
Recruitment status
COMPLETED
Target enrollment
2379 participants
Primary outcome timeframe
Upon receipt of pathology results (within one week)
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Single-arm
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
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Overall Study
STARTED
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2379
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Overall Study
COMPLETED
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1290
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Overall Study
NOT COMPLETED
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1089
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Reasons for withdrawal
| Measure |
Single-arm
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
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Overall Study
Screen Fails/Withdrawal
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1089
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Baseline Characteristics
Colorectal Polyp Clinical Decision Support Device Study
Baseline characteristics by cohort
| Measure |
Single-arm
n=1252 Participants
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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763 Participants
n=99 Participants
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Age, Categorical
>=65 years
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489 Participants
n=99 Participants
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Age, Continuous
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60.6 years
STANDARD_DEVIATION 10.8 • n=99 Participants
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Sex: Female, Male
Female
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601 Participants
n=99 Participants
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Sex: Female, Male
Male
|
651 Participants
n=99 Participants
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Race/Ethnicity, Customized
Caucasian
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976 Participants
n=99 Participants
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Race/Ethnicity, Customized
Asian
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19 Participants
n=99 Participants
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Race/Ethnicity, Customized
African American
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180 Participants
n=99 Participants
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Race/Ethnicity, Customized
Hispanic
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52 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Native American
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4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=99 Participants
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|
Race/Ethnicity, Customized
Middle Eastern
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5 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other
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16 Participants
n=99 Participants
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Region of Enrollment
United States
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1252 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Upon receipt of pathology results (within one week)Population: Total number of polyps from eligible participants (N=1252) who completed the study and had a successful CDSD prediction.
CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results.
Outcome measures
| Measure |
CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp
n=2695 Number of polyps
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
|
Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
Sensitivity for CDSD aided
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90.8 percentage of polyps
Interval 89.3 to 92.3
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Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
Sensitivity for CDSD unaided
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90.7 percentage of polyps
Interval 89.2 to 92.2
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Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
specificity for CDSD aided
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64.7 percentage of polyps
Interval 61.7 to 67.8
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Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology
specificity for CDSD unaided
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59.5 percentage of polyps
Interval 56.6 to 62.7
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SECONDARY outcome
Timeframe: Upon receipt of pathology results (within one week)Population: Patients that completed the study.
pathology as ground truth
Outcome measures
| Measure |
CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp
n=2807 Number of polyps
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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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.
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112 number of polyps without CDSD prediction
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SECONDARY outcome
Timeframe: Upon receipt of pathology results (within one week)Population: patients with polyps
pathology as ground truth
Outcome measures
| Measure |
CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp
n=2695 number of Polyps
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
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2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.
Sensitivity
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88.5 percentage of polyps
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2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.
Specificity
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61.1 percentage of polyps
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2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.
Negative predictive value (NPV)
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74.7 percentage of polyps
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2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light.
Positive predictive value (PPV)
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80.4 percentage of polyps
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SECONDARY outcome
Timeframe: Upon receipt of pathology results (within one week)Population: Patients with polyps with NBI prediction
pathology as ground truth
Outcome measures
| Measure |
CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp
n=2695 Number of Polyps
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
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3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.
Sensitivity
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90.7 percentage of polyps
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3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.
Specificity
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59.5 percentage of polyps
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3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.
PPV
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74.6 percentage of polyps
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3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology.
NPV
|
83.8 percentage of polyps
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SECONDARY outcome
Timeframe: Upon receipt of pathology results (within one week)Population: Patients with CDSD prediction
pathology as ground truth
Outcome measures
| Measure |
CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp
n=2695 Number of polyps
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
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4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
Specificity
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69.5 percentage of polyps
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4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
PPV
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78.6 percentage of polyps
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4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
NPV
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79.9 percentage of polyps
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4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology.
Sensitivity
|
86.5 percentage of polyps
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SECONDARY outcome
Timeframe: Upon receipt of pathology results (within one week)Population: Aided CDSD prediction
pathology as ground truth
Outcome measures
| Measure |
CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp
n=2695 Number of polyps
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
|
|---|---|
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5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.
Sensitivity
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90.8 percentage of polyps
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5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.
Specificity
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64.7 percentage of polyps
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5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.
PPV
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76.8 percentage of polyps
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5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology.
NPV
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85.0 percentage of polyps
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SECONDARY outcome
Timeframe: Upon receipt of pathology results (within one week)Population: NBI unaided prediction vs aided CDSD prediction
pathology as ground truth
Outcome measures
| Measure |
CDSD Un-aided vs. CDSD-aided Predictions of Diminutive Polyp
n=2695 Number of Polyps
CDSD un-aided vs. CDSD-aided predictions of diminutive polyp histology relative to ground-truth pathology. All patients will have both unaided and aided predictions.
Colonoscopy: Standard of care colonoscopy, with added use of CDSD as an adjunctive tool
Clinical Decision Support Device: The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy.
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|---|---|
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6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD
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251 Polyps
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Adverse Events
Single-arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place