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.

ConditionSmall Bowel Bleeding

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age22+

SponsorAnX Robotica Corp.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

Video capsule endoscopy
Phase II = Data analysis by Independent Readers
Phase III = Data Analysis by Expert Readers

Treatment groups

92 Participants

are divided into 1 treatment group

Sponsors and collaborators

AnX Robotica Corp.

Lead sponsor

Source ClinicalTrials.gov