An interventional study of HemoPill acute in Upper GI Bleeding, sponsored by Stony Brook University. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Stony Brook University · Not applicable, Interventional, and Diagnostic
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:
343 studies on the registry are indexed under Gastrointestinal Hemorrhage; 80 are open to participants now.
This study's planned enrollment of 50 is below the median of 86 across 214 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Stony Brook University is the lead sponsor of 197 studies on the registry; 37 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Contraindications to the use of the HemoPill acute including:
Device: HemoPill acute
Participants will ingest the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure.
Sensitivity and specificity
To determine the clinical relationship (sensitivity \& specificity) of blood detection in the upper GI lumen between the HemoPill acute (trial) and endoscopic examination (control).
Time frame: From enrollment to the end of the endoscopic examination.
Clinical effectiveness - Predictive Values
To demonstrate the Negative and Positive Predictive Values by indicating the presence/absence of blood in the upper GI tract.
Time frame: From enrollment to the end of the endoscopic examination.
Transit and excretion
Determination of capsule presence/absence via X-ray radiography \& HemoPill acute receiver connectivity.
Time frame: At Follow-up Visit 1 7-14 days post-ingestion and Follow-up Visit 2 15-21 days post-ingestion (if needed).
Technical effectiveness
To determine rate of successful data transmission of the HemoPill acute to the HemoPill receiver.
Time frame: From enrollment to the end of the endoscopic examination.
Safety profile and complications
To determine the safety profile or rate of adverse events/serious adverse events/complications of the HemoPill acute.
Time frame: From enrollment to Follow-up Visit 1 7-14 days post-ingestion or Follow-up Visit 2 15-21 days post-ingestion (if needed).
Plan to share: Yes — Deidentified individual participant data reported in this article (text, tables, figures, supporting information/data).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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