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.
Starting soon
Conditions studied: Small Bowel Bleeding
In brief
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.
Key facts
- Study ID
- NCT07633847
- Run by
- AnX Robotica Corp.
- People needed
- 92
- Starts
- 2026-06-15
- Expected to finish
- 2028-09-15
- Last updated by the study team
- 2026-06-08
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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