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.

Conditions

• Small Bowel Bleeding

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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).

Study Details

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.

Key Dates

Start date

Jun 15, 2026

Status verified

Jun 2026

Primary completion

Jun 15, 2028

Completion

Sep 15, 2028

Study Design

Enrollment

92 participants (estimated)

Arms

• Arm: NaviCam VCE (video capsule endoscopy)
  Adults 22 years of age or older who received a NaviCam capsule endoscopy procedure

Primary Outcome Measure

Subject-level sensitivity [ Time Frame: 24 months ]

Central Contacts

• Tim Thomas, RAC
  770-480-2911
  [email protected]

Locations (3)

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