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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the HemoPill, designed to detect bleeding in the upper digestive system. The HemoPill, a capsule with a sensor, identifies blood and provides crucial information to doctors. This information could determine the need for further tests or treatments. Individuals scheduled for an endoscopy due to suspected digestive tract bleeding might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to medical advancements and potentially benefit from cutting-edge technology.

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 prior data suggests that the HemoPill device is safe for detecting gastrointestinal bleeding?

Research has shown that the HemoPill, a capsule with a sensor to detect blood in the digestive system, is generally safe for humans. A small initial study found this wireless testing method both practical and safe for identifying sudden bleeding in the stomach or intestines. The capsule is swallowed and moves through the body naturally, eliminating the need for surgery or other invasive procedures. Studies have not reported any major side effects, indicating that patients tolerate the HemoPill well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HemoPill is unique because it provides a non-invasive way to detect gastrointestinal bleeding, which is typically diagnosed through endoscopy. Unlike traditional methods that require direct visualization, the HemoPill uses a capsule that travels through the digestive system, detecting bleeding as it goes, and sends data to a receiver. This innovative approach could lead to earlier detection and treatment, making it a potential game-changer for patients with gastrointestinal issues. Researchers are excited about the HemoPill because it offers a more comfortable and potentially faster diagnostic option compared to current invasive procedures.

What evidence suggests that the HemoPill is effective for detecting gastrointestinal bleeding?

Research has shown that the HemoPill acute effectively detects bleeding in the upper digestive system. One study found that it successfully identifies active bleeding in emergencies and the small intestine. This capsule device, provided to participants in this trial, contains a built-in sensor that detects blood, aiding doctors in making quick diagnoses. Reports also highlight its safety and minimally invasive nature. These features make the HemoPill acute a promising tool for managing digestive system bleeding. ^{1 4 6 7 8}

Who Is on the Research Team?

Melissa Debordeaux, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ovesco.com ovesco.com/products/hemopill/ovesco-hemopill-acute-shows-promising-results-in-emergency-upper-gi-hemorrhage-diagnostics-and-in-detection-of-active-bleeding-in-the-small-intestine/

Ovesco HemoPill® acute shows promising results in ... According to the results of the multicentre data collection, HemoPill acute was shown to be effective in emergency diagnostics. In addition, the authors ...

2. igiejournal.org igiejournal.org/article/S2949-7086(24)00051-7/fulltext

Dueling capsules: novel devices for GI bleeding diagnostics In conclusion, 2 new iGIE reports demonstrate the effectiveness and safety of novel, minimally invasive capsules in managing luminal bleeding.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04472364

HemoPill Acute ® in Suspected Nonvariceal Upper ... The study examines, whether the use of the HemoPill Acute capsule in case of suspected nonvariceal upper gastrointestinal bleeding can identify cases in which ...

4. endoscopyonair.com endoscopyonair.com/wp-content/uploads/2021/05/6-OVE_EoA_HemoPill_PDF_Collection_2021-05-12.pdf

Immediate blood detection - HemoPill® acute We report our experience with HemoPill acute in patients with suspected gastrointestinal bleeding during the current SARS-CoV2 pandemic. Results.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8383089/

Effectiveness of hemostatic powders in lower ... Immediate hemostasis was achieved in 95 % of patients (95 % confidence interval [CI] 91.6 %–98.5 %), with no difference based on treatment strategy or bleeding ...

6. ovesco.com ovesco.com/hemopill/

Ovesco Endoscopy AG - HemoPill® HemoPill is a new product line for the immediate detection of acute bleeding in the oesophagus, stomach, and small intestine.

7. fcc.report fcc.report/FCC-ID/2AYFH-OVE-HP/5173711.pdf

HemoPill® ACUTE The HemoPill acute is used for diagnosis in patients with suspected acute bleeding in the esophagus, stomach, and small intestine. The ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6524997/

Novel telemetric sensor capsule for EGD urgency triage In conclusion, detection of acute UGIB with the novel sensor capsule proved to be feasible and safe. The swallowable sensor capsule directly responds to ...