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 | Not Yet Recruiting FDA Device

• 1 other identifier: P05-CEP-0002
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

artificial intelligent; assisted reading tool; capsule endoscopy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

NaviCam VCE (video capsule endoscopy)

Adults 22 years of age or older who received a NaviCam capsule endoscopy procedure

Device: Video capsule endoscopy; Other: Phase II = Data analysis by Independent Readers; Other: Phase III = Data Analysis by Expert Readers

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.

NaviCam VCE (video capsule endoscopy)

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.

NaviCam VCE (video capsule endoscopy)

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).

NaviCam VCE (video capsule endoscopy)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 22 years old or older

You may qualify if:

• 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.

You may not qualify if:

• 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.
• GI motility issues (gastroparesis)
• GI dysmotility
• Chronic opioid usage
• Requires endoscopic placement
• In patients with endoscopic biopsies within one week of scheduled capsule ingestion
• No NSAID use within 14 days of scheduled capsule ingestion
• No GLP-1 drugs within 7 days of scheduled capsule ingestion

Sponsors & Collaborators

• AnX Robotica Corp.: lead

Study Sites (3)

NYU Langone Health

New York, New York, 10016, United States

Location

NYU Grossman School of Medicine

New York, New York, 10022, United States

Location

Digestive Health Associates of Texas

Bedford, Texas, 76002, United States

Location

MeSH Terms

Interventions

Capsule Endoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Shabana Pasha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim Thomas, RAC

CONTACT

770-480-2911; tim.thomas@anxrobotics.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (3)