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Completed
NCT05631652
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Conditions: Upper Gastrointestinal Bleeding
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 10
Sponsor: EnteraSense Limited
Location: Czechia
Summary
The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.
Eligibility Criteria
Inclusion Criteria:Age 18 -60 yearsAbility to give written informed consentExclusion 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 tractPresence of pacemaker or other implantable electronic 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)Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigationActive psychological issues preventing participationStomach bezoarHistory of severe esophagitisHistory of Crohn diseaseHistory of diverticulitisHistory of bowel obstructionSuspected gastrointestinal tumor diseasePlanned MRI investigation (MRI needed before the capsule is excreted)
Source: ClinicalTrials.gov (NCT05631652). StuddyBuddy aggregates publicly available trial information.