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.
Patients of all genders, races, ethnicities and geographical backgrounds, from 22 years of age or older.
Patient agrees to sign informed consent and follow all study procedures.
In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
In patients with cardiac pacemakers or other implantable electronic medical devices (MR unsafe devices only).
In patients with dysphagia with high risk of aspiration.
In pregnant women.
Adults 22 years old or older
Case-only
Prospective
Video capsule endoscopy
DevicePhase 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.
Phase II = Data analysis by Independent Readers
Other interventionIndependent 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 interventionAn Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II).
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.
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.
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