HemoPill for Gastrointestinal Bleeding

Overseen By Sofia Yuen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Gastrointestinal obstruction, Dysphagia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the HemoPill acute, a swallowable capsule that detects blood in the upper digestive system. It targets patients suspected of having upper digestive tract bleeding. The capsule helps doctors by providing additional information about internal bleeding.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment HemoPill for gastrointestinal bleeding?

The HemoPill is a sensor capsule that helps detect blood in the upper gastrointestinal tract, which can aid in the timely diagnosis of bleeding. It has been evaluated in clinical settings for its ability to provide real-time blood detection, which is crucial for managing acute bleeding events. ^{1 2 3 4 5}

Is the HemoPill safe for detecting gastrointestinal bleeding?

The HemoPill, a sensor capsule used to detect blood in the gastrointestinal tract, has been evaluated in clinical settings, but specific safety data for humans is not detailed in the available research. However, no adverse events related to its use are mentioned, suggesting it may be generally safe. ^{3 4 5 6 7}

How is the HemoPill treatment different from other treatments for gastrointestinal bleeding?

The HemoPill is unique because it is a pill-shaped sensor capsule that patients swallow to detect bleeding in the upper gastrointestinal tract in real-time, unlike traditional treatments that require endoscopic procedures. This telemetric approach allows for timely diagnosis and monitoring without invasive methods. ^{1 3 4 5 8}

Research Team

Melissa Latorre, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 who may have bleeding in their upper digestive tract, are able to give informed consent, and are already scheduled for an endoscopy. It's not for those with GI obstructions, swallowing disorders, pregnant women or people with pacemakers or similar devices.

Inclusion Criteria

Signed informed consent

I am willing and able to follow the study's procedures.

I am scheduled for an endoscopy because of suspected upper GI bleeding.

Exclusion Criteria

I don't have any blockages or abnormal passages in my digestive tract.

I am unable to understand or sign the consent form.

Contraindications to the use of the HemoPill acute, such as patients with cardiac pacemakers and other implanted medical devices

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Endoscopy Preparation

Participants ingest the HemoPill acute capsule shortly before the scheduled endoscopy

Approximately 20-60 minutes

1 visit (in-person)

Endoscopy and Treatment

Endoscopy is performed to identify and treat any bleeding pathologies as per clinical standard

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the endoscopy procedure

1-2 weeks

Treatment Details

Interventions

• HemoPill

Trial Overview The HemoPill is being tested; it's a capsule with a sensor that detects blood in the upper digestive tract. This could help doctors decide more quickly if someone needs further medical attention based on better detection of internal bleeding.

Participant Groups

Group I: HemoPill group Experimental Treatment 2 Interventions

Participants who have scheduled endoscopies will be given the HemoPill acute capsule and the HemoPill Receiver will be activated (connected to the HemPill). Approximately 20 to 60 minutes after HemoPill acute capsule ingestion, the endoscopy will start. The attending physician will proceed with the endoscopic intervention in accordance with clinical practice and NYU protocols, which is a standard procedure. In the case bleeding pathologies are found, these will be endoscopically treated as per clinical standard.For later evaluation of the HemoPill acute measurement, a statistical correlation of the obtained data from the HemoPill Acute measurement with the endoscopic findings will be performed. The HemoPill acute capsule travels through and leaves the body naturally

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

References

1. Hungary pubmed.ncbi.nlm.nih.gov

[Hemospray: a novel therapeutic option in the management of acute upper gastrointestinal bleeding]. [2015]

2. Australia pubmed.ncbi.nlm.nih.gov

Outcomes from an international multicenter registry of patients with acute gastrointestinal bleeding undergoing endoscopic treatment with Hemospray. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Volunteer Case Series of a New Telemetric Sensor for Blood Detection in the Upper Gastrointestinal Tract: The HemoPill. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Telemetric capsule-based upper gastrointestinal tract - blood detection - first multicentric experience. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Pre-clinical study on a telemetric gastric sensor for recognition of acute upper gastrointestinal bleeding: the "HemoPill monitor". [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Barriers to Guideline-Based Use of Proton Pump Inhibitors to Prevent Upper Gastrointestinal Bleeding. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Hemostatic powder spray: a new method for managing gastrointestinal bleeding. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Hemospray (TC-325) in the Treatment of Gastrointestinal Bleeding: An Updated Systematic Review and Meta-analysis. [2021]