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Detection of Blood in the GI Lumen With HemoPill Acute

Study acronym: DIRECT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The goal of this clinical trial is to learn if the HemoPill acute (trial device) can detect the presence of blood in participants suspected of having upper gastrointestinal bleeding. The main question it aims to answer is: -What is the clinical relationship between the HemoPill acute (trial device) and endoscopy (control procedure) in detecting the presence of blood/bleeding in the upper gastrointestinal tract? Participants will: * Swallow the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure. * Keep the device receiver close to their body from the time of swallowing until completion of their endoscopy procedure. * Return for a follow-up visit(s) to check for the presence or absence of the HemoPill acute device and to report the occurrence of any adverse or serious adverse events.
Trial Details
NCT Number NCT07868068
Lead Sponsor Stony Brook University
Collaborators: Ovesco Endoscopy AG
Conditions
(from sponsor)
Upper GI Bleeding
Related terms Gastrointestinal Hemorrhage
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov