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This study is to assess the sensitivity and added benefits of CADEYE compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Failure in polyp recognition is a major determinant for the high rate of missed colorectal neoplasms. In response, technological advances have paved the way for Computer-Aided Polyp Detection (CAD-e) systems. Artificial intelligence systems allow of real-time computer- aided detection of polyps with high-accuracy. CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure.
The data generated from this study will provide an estimate of the ADR throughout the Middle East as well as assess the accuracy of CADEYE in detecting adenomas in comparison to standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing White Light Endoscopy (standard of care) | No Intervention | All subjects in Experimental Arm A will undergo SOC (white-light endoscopy). | |
| Patients undergoing CAD EYE endoscopy | Experimental | All subjects in Experimental Arm B will undergo CADEYE endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD EYE (Computer Aided Diagnosis ----? | Diagnostic Test | CADEYE is a CAD-e system (FUJIFILM) that enables real-time video processing at the same rate as the standard procedure and and allows a real time computer aided detection of polyps with high accuracy. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | Adenoma detection rate is the primary end point which is the percentage of patients with at least 1 histologically proven adenoma or carcinoma. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adenomas detected per colonoscopy | 1 year | |
| Proximal Adenoma detection rate | 1 year | |
| Withdrawal time |
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Inclusion Criteria:
40-80 years old subjects
Subjects undergoing colonoscopy for the following: o Primary CRC screening
Subjects must be willing to give written informed consent for the trial
Exclusion Criteria:
Unable to consent
Contraindicated to undergo endoscopy
Hospitalized patient
Patients with the following conditions:
Pregnant or lactating
Poor bowel preparation: BBPS 0 or 1 in a segment
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Ibrahim, M.D PhD | Contact | 01006107100 | mostafa.ibrahim@webgit.net | |
| Farah Ebrahim, Medicine | Contact | 01066443936 | Farah.Ahmed@roeyaegypt.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Theodor Bilharz Research Institute | Recruiting | Giza | 12311 | Egypt |
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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 | Mar 12, 2021 | Aug 29, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2022 | Aug 29, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003936 | Diagnosis, Computer-Assisted |
| ID | Term |
|---|---|
| D003933 | Diagnosis |
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| 1 year |
| Non-neoplastic detection rate | 1 year |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |