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NCT Number: NCT07633847

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.

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Grossman School of Medicine, New York, United States

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About this study

The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. ProScan also assists small bowel endoscopy reviewers in identifying the digestive tract location (oral cavity and beyond, esophagus, stomach, small bowel) of the image in adults. The tool is not intended to replace clinical decision making.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Subject-level sensitivity

    Time frame: 24 months

    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.

  2. Subject-level specificity

    Time frame: 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tim Thomas, RAC

CONTACT

[email protected]

770-480-2911

Sponsors and collaborators

Lead sponsor

AnX Robotica Corp.

Industry

Registry information

Official study title

Prospective Study Exploring the Difference of AI-Trained Software Compared to Conventional Interpretation Methods in Small Bowel Video Capsule Procedures

Acronym: PROCEED

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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