Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study

This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).

Inclusion Criteria:Age 18 -80 yearsAbility to give written informed consentClinical suspicion of bleedingExclusion Criteria:Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure <100 mmHg,heart rate > 100 / min)Known current stenosis of the GI tractSubject is using a pacemaker or other implantable electrical deviceDysphagia or difficulties in swallowing pills the size of the capsuleHistory of achalasia or known esophageal dysmotilityHistory of gastroparesisHistory of severe constipation (1 bowel movement per week or less)Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigationPresence of psychological issues preventing participationStomach bezoarHistory of Crohn diseaseHistory of diverticulitisHistory of bowel obstructionSuspected gastrointestinal tumor diseasePlanned MRI investigation (MRI needed before the capsule is excreted)