Small Bowel Bleeding
Conditions
Keywords
artificial intelligent, assisted reading tool, capsule endoscopy
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.
Detailed description
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.
Interventions
DEVICEVideo capsule endoscopy
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.
OTHERPhase II = Data analysis by Independent Readers
Independent video capsule readers to review and evaluate the videos from the capsule endoscopy procedure (Phase I), plus the ProScan videos.
OTHERPhase III = Data Analysis by Expert Readers
An Expert Panel will read all videos to create a database comparing the Physician results (Phase I) and the ProScan + Physician results (Phase II).
Sponsors
AnX Robotica Corp.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-level sensitivity | 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. |
| Subject-level specificity | 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. |
Countries
United States
Contacts
CONTACTTim Thomas, RAC
PRINCIPAL_INVESTIGATORShabana Pasha, MD
Mayo Clinic
Outcome results
None listed