| Primary | Difference in Adenomas Per Colonoscopy (APC) | Difference in Adenomas Per Colonoscopy (APC) between the control and intervention arm, evaluated for superiority. APC is defined as the average number of histologically confirmed adenomas resected per colonoscopy. | | Posted | | Least Squares Mean | 95% Confidence Interval | Resected adenomas | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.60(0.56 to 0.64)
- OG0010.74(0.71 to 0.77)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Poisson Regression | | 0.0002 | Threshold for significance is 0.025. | Mean Difference (Final Values) | 0.14 | | | 2-Sided | 95 | 0.07 | 0.23 | | | | | Superiority | | |
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| Primary | Difference in Positive Percent Agreement (PPA) | Difference in Positive Percent Agreement (PPA) between the control and intervention arm, evaluated for non-inferiority. PPA is defined as the total number of histologically confirmed Clinically Significant Excised Lesions, divided by the total number of excisions. | | Posted | | Least Squares Mean | 95% Confidence Interval | Proportion of significant lesions | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Adenoma Detection Rate (ADR) | The Adenoma Detection Rate is defined as the number of patients with at least one histologically confirmed adenoma divided by the total number of patients enrolled per study arm. | | Posted | | Number | 95% Confidence Interval | Percentage of participants with adenomas | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Number of False Alerts Per Procedure | A false alert is defined as a bounding box that persists on the screen (approximately 2-3 seconds per the judgment of the colonoscopist) that is then determined by the colonoscopist not to contain a polyp. The false alert rate is calculated as the number of false alerts per procedure conducted in the intervention arm of the study. | | Posted | | Number | | Number of false alerts | | Day 1 | | | | ID | Title | Description |
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| OG000 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Mean Withdrawal and Inspection Time (MWT) | The withdrawal time is defined as the time measured from the moment the withdrawal phase of the procedure begins (with the scope in the cecum) to the moment the scope is withdrawn from the patient. The Inspection time measurement will exclude washing and resection, and other peri-resection activity not deemed to be colonic inspection. Inspection times for both the control arm and intervention arm will be calculated retrospectively upon review of the video recordings. | Convenience sample of available videos | Posted | | Mean | Standard Deviation | minutes | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Polyp Detection Rate (PDR) | Polyp detection rate is defined as the proportion of patients with at least one histologically-confirmed polyp detected. | | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Proximal Adenoma Detection Rate (pADR) | pADR is defined as the percentage of patients with at least one histologically-confirmed adenoma detected in proximal colon. | | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Flat Adenoma Detection Rate (fADR) | fADR is defined as the percentage of patients with at least one histologically-confirmed non-polypoid adenoma detected. | | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Serrated Lesions Per Colonoscopy (SLPC) | SLPC is defined as the number of histologically confirmed serrated lesions detected, divided by the total number of colonoscopies. | | Posted | | Least Squares Mean | 95% Confidence Interval | serated lesions per colonoscopy | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Serrated Lesions Detection Rate (SLDR) | SLDR is defined as the percentage of patients with at least one histologically confirmed serrated lesion detected. | | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Adenoma Detection Rate Including Carcinoma (ADR*) | ADR* is defined as ADR, but also includes histologically-confirmed intramucosal carcinoma and adenocarcinoma. | | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Small Adenoma Detection Rate (sADR) | sADR is defined as the percentage of patients with at least one adenoma 5mm or smaller detected. | | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Polyps Per Colonoscopy (PPC) | PPC is defined as the total number of histologically-confirmed polyps found divided by the total number of colonoscopies performed, per study arm. | | Posted | | Least Squares Mean | 95% Confidence Interval | Polyps per colonoscopy | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | Advanced Adenoma Detection Rate (aADR) | aADR is defined as the percentage of patients with at least one adenoma ≥ 10 mm, or any adenoma < 10 mm, which was either of high-grade dysplasia (HGD) or villous or tubulovillous. | | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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| Secondary | False Positive Rate (FPR) | FPR is defined as the proportion of colorectal lesions resected and biopsied and subsequently not histologically-confirmed to be clinically relevant colorectal polyps (e.g. a pathology finding of normal mucosa, inflammatory tissue, stool or debris, lymphoid aggregates). | | Posted | | Least Squares Mean | 95% Confidence Interval | proportion of resected lesions | | Day 1 | Resected lesions | Resected lesions | | ID | Title | Description |
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| OG000 | Colonoscopy (Standard of Care) | The control arm is colonoscopy with High Definition White Light Endoscopy (HD-WLE) per standard of care. | | OG001 | CADe Device | The intervention arm is colonoscopy with HD-WLE per standard of care plus the CADe Device. Computer-Assisted Detection (CADe) Device: The CADe Device uses artificial intelligence to aid in identifying colorectal polyps during High Definition White Light Endoscopy (HD-WLE) based colonoscopies. This device connects the Gastroenterologist's colonoscopy video output source to the main monitor and highlights the regions of interest where the device detects a potential lesion. The CADe Device overlays graphical markers onto video from the endoscope camera and does not perform further processing to the endoscope video signal. This device is not intended to replace clinical decision making. |
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