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.

N/ANot Yet RecruitingNCT07633847

AnX Robotica Corp.92 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Small Bowel Bleeding

Interventions

Video capsule endoscopyDEVICE

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.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (3)

NYU Langone Health

New York, New York, United States

NYU Grossman School of Medicine

New York, New York, United States

Digestive Health Associates of Texas

Bedford, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.