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A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.
Sponsor: AnX Robotica Corp.
Summary
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.
Official title: Prospective Study Exploring the Difference of AI-Trained Software Compared to Conventional Interpretation Methods in Small Bowel Video Capsule Procedures
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
92
Start Date
2026-06-15
Completion Date
2028-09-15
Last Updated
2026-06-08
Healthy Volunteers
No
Conditions
Interventions
Video capsule endoscopy
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.
Phase II = Data analysis by Independent Readers
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
An Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II).
Locations (3)
NYU Langone Health
New York, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Digestive Health Associates of Texas
Bedford, Texas, United States