Upper GI BleedingDIRECTNCT07868068
Detection of Blood in the GI Lumen With HemoPill Acute
A study testing HemoPill acute in people with Upper GI Bleeding, run by Stony Brook University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Upper GI Bleeding
- What is being tested?
- HemoPill acute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
Joseph LaComb, 631-444-9532, joseph.lacomb@stonybrookmedicine.edu
Vivek Kesar, MBBS
About this study
Official title: Detection of Blood in the GI Lumen With HemoPill Acute - Relation Between Endoscopy and HemoPill Acute Measurement
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?
Read more
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.
- Conditions
- Upper GI Bleeding
- Being tested
- HemoPill acute
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoPill acuteDevice
Participants will ingest the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| HemoPill acute | Experimental | Not described Receives: Device: HemoPill acute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of the endoscopic examination.
Secondary outcomes (4)
Clinical effectiveness - Predictive Values
To demonstrate the Negative and Positive Predictive Values by indicating the presence/absence of blood in the upper GI tract.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to Follow-up Visit 1 7-14 days post-ingestion or Follow-up Visit 2 15-21 days post-ingestion (if needed).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper GI BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Ovesco Endoscopy AG
- Responsible party
- Principal investigator, Vivek Kesar, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868068
- Sponsor's protocol ID
- IRB2025-00712
- Acronym
- DIRECT
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual participant data reported in this article (text, tables, figures, supporting information/data).