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50 Participants NeededMy employer runs this trial

HemoPill Acute for Gastrointestinal Bleeding

(DIRECT Trial)

JL
Overseen ByJoseph LaComb
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stony Brook University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for people who are suspected of having bleeding in their upper digestive tract, such as from a stomach ulcer. Participants must be scheduled for an endoscopy and able to swallow the HemoPill device.

Inclusion Criteria

I am 22 years old or older.
Literate and able to provide written informed consent
I am scheduled for an upper endoscopy because of possible upper GI bleeding.

Exclusion Criteria

Not literate or unable to provide written informed consent
Contraindications to the use of the HemoPill acute including dysphagia, Zenker's diverticulum, or other swallowing disorders
Presence of cardiac pacemakers or other implanted electrical device(s)
See 6 more

What Are the Treatments Tested in This Trial?

Interventions

  • HemoPill acute

Trial Overview

The study tests if the HemoPill acute capsule can detect blood in the upper digestive tract compared to standard endoscopy. Participants swallow the device before their routine procedure and keep a receiver nearby.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: HemoPill acuteExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials
225
Recruited
41,700+

Ovesco Endoscopy AG

Industry Sponsor

Trials
5
Recruited
420+

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