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.
Not Yet Recruiting
Not specifiedAges 22+ObservationalAnX Robotica Corp.
~92 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Video capsule endoscopyPhase II = Data analysis by Independent ReadersPhase III = Data Analysis by Expert Readers
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Subject-level sensitivity
Measured over 24 months
+1 more outcome measured
Conditions
Where it's being run
3 sites across 2 statesNew York2
Texas1
Study leadership
- Shabana Pasha, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Subject-level sensitivity24 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 specificity24 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.