What side effects are associated with this type of intervention?

Common treatments for upper gastrointestinal bleeding include endoscopic therapy and the use of medications such as proton pump inhibitors (PPIs). Endoscopic therapy, which may involve epinephrine injection, thermal coagulation, or hemoclips, can sometimes lead to complications like perforation or rebleeding. High-dose intravenous esomeprazole, a PPI, is generally well-tolerated but can cause side effects such as headache, diarrhea, and abdominal pain. Capsule endoscopy, similar to the HemoPill acute, is noninvasive but may be contraindicated in patients with small bowel obstruction or those unable to swallow the capsule.

What prior FDA approvals exist?

The FDA has approved various treatments for upper gastrointestinal bleeding, primarily focusing on pharmacological and endoscopic interventions. Commonly approved drugs include proton pump inhibitors (PPIs) like omeprazole and esomeprazole, which reduce stomach acid and help manage bleeding. Endoscopic techniques, such as endoscopic hemostasis using clips, bands, or thermal coagulation, are also standard treatments. While the HemoPill acute represents a novel diagnostic approach with its built-in sensor to detect blood, similar FDA-approved diagnostic devices include capsule endoscopy, which allows for visualization and diagnosis of bleeding sources in the GI tract. However, specific FDA approvals for capsule devices with built-in sensors like the HemoPill acute are not detailed in the provided context.

What other types of research exist?

Promising novel alternatives to the HemoPill acute for detecting upper gastrointestinal bleeding include: 1) Point-of-care musculoskeletal ultrasound (POC-MSKUS), which is non-invasive and useful for identifying hemorrhage, and 2) Advanced endoscopic techniques with enhanced imaging capabilities. These methods provide valuable diagnostic information and complement traditional laboratory and clinical tests.

← Back to Search

Capsule Device

HemoPill for Gastrointestinal Bleeding

N/A

Recruiting

Led By Melissa Latorre, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Be older than 18 years old

Must not have

Contraindications to the use of the HemoPill acute, such as known gastrointestinal obstruction, stricture, fistula, or diverticula

Incapacity to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour after endoscopy procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here but might include discomfort from swallowing the capsule or possible interactions with other medical conditions like gastrointestinal obstructions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I am unable to understand or sign the consent form.

Select...

I do not have trouble swallowing or any swallowing disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour after endoscopy procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour after endoscopy procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour after endoscopy procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of False negative results

Number of False positive results

Number of True negative results

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HemoPIll groupExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Upper Gastrointestinal Bleeding (UGIB) include proton pump inhibitors (PPIs), endoscopic therapy, and blood transfusions. PPIs work by reducing gastric acid production, which helps stabilize clots and promotes healing of the mucosa. Endoscopic therapy involves techniques such as clipping, banding, or injecting sclerosing agents to directly stop the bleeding. Blood transfusions are used to manage significant blood loss and maintain hemodynamic stability. These treatments are crucial for UGIB patients as they address both the immediate need to stop bleeding and the longer-term goal of preventing rebleeding. The HemoPill acute device complements these treatments by providing real-time detection of blood in the upper digestive tract, allowing for timely and targeted therapeutic interventions.