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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.

NCT07633847 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

  • Small Bowel Bleeding

Interventions

DEVICE

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.

OTHER

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.

OTHER

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).

Sponsors & Collaborators

  • AnX Robotica Corp.

    lead INDUSTRY

Principal Investigators

  • Shabana Pasha, MD · Mayo Clinic

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-06-15
Completion
2028-09-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633847 on ClinicalTrials.gov