HemoPill Acute to Detect Blood in Upper GI Tract Before Endoscopy
Official title: Detection of Blood in the GI Lumen With HemoPill Acute - Relation Between Endoscopy and HemoPill Acute Measurement
Run by Stony Brook University · NCT07868068 · Data updated 2026-11-12
This study tests whether the HemoPill acute can detect blood in patients suspected of upper GI bleeding before they undergo endoscopy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Stony Brook University Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Status | Recruiting |
| Started | October 2026 |
| Main results expected | July 2027 |
| Study ends | October 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07868068 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 22 years and older who are scheduled for upper endoscopy due to suspected upper GI bleed and can provide informed consent.
✕Probably not a fit
Patients without successful device detection or with contraindications to use may not benefit from the device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the HemoPill acute device to see if it can identify blood in the upper GI tract when used before a scheduled endoscopy. Participants swallow the device 1–4 hours prior and keep the receiver nearby until endoscopy, then return for follow-up to assess results and any adverse events. The endoscopy serves as the standard procedure for comparison. The trial will enroll adults aged 22 and older who are awaiting upper GI endoscopy for suspected bleeding. Safety considerations include swallowing-related contraindications and device-compatibility factors.
Why it matters
Potential benefit: If successful, the device could provide a quick, noninvasive indication of GI bleeding to inform and streamline care.
How similar studies have gone: Prior approaches to noninvasive bleeding detection in the GI tract have shown mixed results; this study tests a novel swallowing device with endoscopy correlation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Stony Brook University
Stony Brook, New York, United States Recruiting
Study contacts
- Study coordinator: Joseph LaComb
- Email: joseph.lacomb@stonybrookmedicine.edu
- Phone: 631-444-9532
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.