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Detection of Blood in the GI Lumen With HemoPill Acute

RecruitingNAAges 22 Years - anyAllStony Brook University
NCT07868068 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Greater than or equal to 22 years of age. * Scheduled for upper endoscopy due to suspicion of upper GI bleed as part of standard of clinical care. * Literate and able to provide written informed consent. Exclusion Criteria: * Less than 22 years of age. * Not undergoing upper endoscopy due to suspicion of upper GI bleed as part of standard of clinical care. * Contraindications to the use of the HemoPill acute including: 1. Known GI obstruction, stricture, or fistula; 2. Dysphagia, Zenker's diverticulum, or other swallowing disorders; 3. Achalasia or other esophageal dysmotility. * Cardiac pacemakers or other implanted electrical device(s). * Circulatory or hemodynamic instability at the discretion/determination of the attending endoscopist and clinical care team. * Pregnant or breastfeeding. * Not literate or unable to provide written informed consent.
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What it tests

  • HemoPill acute
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Where

1 site
Stony Brook University
Stony Brook, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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