What this study is
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.
What's being tested
- HemoPill acute
Intervention · DEVICE
Participants will ingest the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure.
Study details
- Official title
- Detection of Blood in the GI Lumen With HemoPill Acute - Relation Between Endoscopy and HemoPill Acute Measurement
- Sponsor
- Stony Brook University
- Conditions
- Upper GI Bleeding
- Enrolling
- 50 people
- Starts
- 2026-10
- Est. completion
- 2027-10
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 22 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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:; Known GI obstruction, stricture, or fistula;; Dysphagia, Zenker's diverticulum, or other swallowing disorders;; 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStony Brook University
Stony Brook, New York, United States
- Joseph LaComb · Contact631-444-9532joseph.lacomb@stonybrookmedicine.edu
- Vivek Kesar, MBBS · Principal investigator
Recruiting
Study team
Sponsor
Stony Brook University
Study ID IRB2025-00712
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.