Detection of Blood in the GI Lumen With HemoPill Acute

NCT07868068 | Recruiting DMC FDA Device

• 1 other identifier: IRB2025-00712
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Upper GI Bleeding

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to the end of the endoscopic examination.

Secondary Outcomes (4)

• Clinical effectiveness - Predictive Values

  From enrollment to the end of the endoscopic examination.

• Transit and excretion

  At Follow-up Visit 1 7-14 days post-ingestion and Follow-up Visit 2 15-21 days post-ingestion (if needed).

• Technical effectiveness

  From enrollment to the end of the endoscopic examination.

• Safety profile and complications

  From enrollment to Follow-up Visit 1 7-14 days post-ingestion or Follow-up Visit 2 15-21 days post-ingestion (if needed).

Study Arms (1)

HemoPill acute

EXPERIMENTAL

Device: HemoPill acute

Interventions

HemoPill acute DEVICE

Participants will ingest the HemoPill acute device one (1) to four (4) hours before their scheduled standard of care endoscopy procedure.

HemoPill acute

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Stony Brook University: lead
• Ovesco Endoscopy AG: collaborator

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joseph LaComb

CONTACT

631-444-9532; joseph.lacomb@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)