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The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy | Procedure | Standard of care colonoscopy, with added use of CDSD as an adjunctive tool |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology | CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results. | Upon receipt of pathology results (within one week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pathology as ground truth | Upon receipt of pathology results (within one week) |
| 2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borland Groover | Jacksonville | Florida | 32256 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38768450 | Derived | Rex DK, Bhavsar-Burke I, Buckles D, Burton J, Cartee A, Comar K, Edwards A, Fennimore B, Fischer M, Gerich M, Gilmore A, Hamdeh S, Hoffman J, Ibach M, Jackson M, James-Stevenson T, Kaltenbach T, Kaplan J, Kapur S, Kohm D, Kriss M, Kundumadam S, Kyanam Kabir Baig KR, Menard-Katcher P, Kraft C, Langworthy J, Misra B, Molloy E, Munoz JC, Norvell J, Nowak T, Obaitan I, Patel S, Patel M, Peter S, Reid BM, Rogers N, Ross J, Ryan J, Sagi S, Saito A, Samo S, Sarkis F, Scott FI, Siwiec R, Sullivan S, Wieland A, Zhang J, Repici A, Hassan C, Byrne MF, Rastogi A. Artificial Intelligence for Real-Time Prediction of the Histology of Colorectal Polyps by General Endoscopists. Ann Intern Med. 2024 Jul;177(7):911-918. doi: 10.7326/M24-0086. Epub 2024 May 21. |
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Immediately - 3 years
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eligible patients that rec'd a colonoscope and a successful CDSD prediction.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Specificity and Sensitivity CDSD-unaided and CDSD-aided Endoscopist Predictions of Diminutive Polyp Histology | CDSD-unaided and CDSD-aided predictions will be compared with the ground truth pathology results. | Total number of polyps from eligible participants (N=1252) who completed the study and had a successful CDSD prediction. | Posted | Number | 95% Confidence Interval | percentage of polyps | Upon receipt of pathology results (within one week) | Number of polyps | Number of polyps |
|
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Deaths and adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Bolt, Global GI Lead | Olympus Corporation | 5085798495 | jeremy.bolt@olympus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2020 | Mar 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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The study shall be a prospective, single arm, multicenter study.
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The pathologist (outcomes assessor) is blinded to the endoscopist predictions and CDSD prediction.
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| Clinical Decision Support Device | Device | The investigational device consists of software residing on a dedicated computer enabling display of predicted diminutive polyp histology during colonoscopy. |
|
|
pathology as ground truth |
| Upon receipt of pathology results (within one week) |
| 3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology. | pathology as ground truth | Upon receipt of pathology results (within one week) |
| 4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology. | pathology as ground truth | Upon receipt of pathology results (within one week) |
| 5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology. | pathology as ground truth | Upon receipt of pathology results (within one week) |
| 6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD | pathology as ground truth | Upon receipt of pathology results (within one week) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | During the screening process, patients were asked their race and ethnicity. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | pathology as ground truth | Patients that completed the study. | Posted | Number | number of polyps without CDSD prediction | Upon receipt of pathology results (within one week) | Number of polyps | Number of polyps |
|
|
|
| Secondary | 2. Sensitivity, Specificity, Negative Predictive Value (NPV), Positive Predictive Value (PPV) of Unaided Endoscopist Prediction Using White Light. | pathology as ground truth | patients with polyps | Posted | Number | percentage of polyps | Upon receipt of pathology results (within one week) | number of Polyps | number of Polyps |
|
|
|
| Secondary | 3. Sensitivity, Specificity, NPV, PPV of Unaided Endoscopist Prediction Using NBI Compared With Pathology. | pathology as ground truth | Patients with polyps with NBI prediction | Posted | Number | percentage of polyps | Upon receipt of pathology results (within one week) | Number of Polyps | Number of Polyps |
|
|
|
| Secondary | 4. Sensitivity, Specificity, NPV, PPV of CDSD Prediction Compared With Pathology. | pathology as ground truth | Patients with CDSD prediction | Posted | Number | percentage of polyps | Upon receipt of pathology results (within one week) | Number of polyps | Number of polyps |
|
|
|
| Secondary | 5. Sensitivity, Specificity, NPV, PPV of CDSD-aided Endoscopist Prediction Compared With Pathology. | pathology as ground truth | Aided CDSD prediction | Posted | Number | percentage of polyps | Upon receipt of pathology results (within one week) | Number of polyps | Number of polyps |
|
|
|
| Secondary | 6. Number of Pathology Results for Diminutive Polyps With Discordant Unaided Predictions Using NBI and Aided Predictions With CDSD | pathology as ground truth | NBI unaided prediction vs aided CDSD prediction | Posted | Number | Polyps | Upon receipt of pathology results (within one week) | Number of Polyps | Number of Polyps |
|
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| 0 |
| 0 |
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| 0 |
| 0 |
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| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Title | Measurements |
|---|---|
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| Positive predictive value (PPV) |
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| Title | Measurements |
|---|---|
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| NPV |
|
| Title | Measurements |
|---|---|
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| NPV |
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| Title | Measurements |
|---|---|
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| NPV |
|