Detection of Blood in the GI Lumen With HemoPill Acute

Conditions

• Upper GI Bleeding

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Oct 9, 2026

Start date

Oct 31, 2026

Status verified

Oct 2026

Primary completion

Jul 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: HemoPill acute

Primary Outcome Measure

Sensitivity and specificity [ Time Frame: From enrollment to the end of the endoscopic examination. ]

Central Contacts

• Joseph LaComb
  631-444-9532
  [email protected]

Locations (1)

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