Recruiting

HemoPill Acute

Sponsor:

Stony Brook University

Code:

NCT07868068

Conditions

Upper GI Bleeding

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

HemoPill acute

Study Details

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

Study ID

NCT07868068

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: HemoPill acute

Interventions

HemoPill acute

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joseph LaComb

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

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Joseph LaComb

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

Principal Investigator:

Vivek Kesar, MBBS

More Information

Sponsor

Stony Brook University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.