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NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.
The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. The tool is not intended to replace clinical decision making.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaviCam VCE (video capsule endoscopy) | Adults 22 years of age or older who received a NaviCam capsule endoscopy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video capsule endoscopy | Device | Phase I = Data Collection. The video from the capsule endoscopy procedure will be reviewed and reported by the treating physician. Once the capsule has passed and any adverse events have been collected, there will be no additional patient follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-level sensitivity | Subject-level sensitivity will be evaluated for superiority of ProScan assistance versus unassisted assessments in the identification of patients with one or more true findings. | 24 months |
| Subject-level specificity | Subject-level sensitivity will be evaluated for non-inferiority of superiority of ProScan assistance versus unassisted assessments in the identification of patients with no ground truth findings. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults 22 years old or older
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Thomas, RAC | Contact | 770-480-2911 | tim.thomas@anxrobotics.com |
| Name | Affiliation | Role |
|---|---|---|
| Shabana Pasha, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| Phase II = Data analysis by Independent Readers | Other | Independent video capsule readers to review and evaluate the videos from the capsule endoscopy procedure (Phase I), plus the ProScan videos. |
|
| Phase III = Data Analysis by Expert Readers | Other | An Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II). |
|
| NYU Grossman School of Medicine | New York | New York | 10022 | United States |
|
| Digestive Health Associates of Texas | Bedford | Texas | 76002 | United States |
|
| ID | Term |
|---|---|
| D053704 | Capsule Endoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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