HemoPill for Gastrointestinal Bleeding

Palo Alto (17 mi)

Overseen byMelissa Latorre, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: NYU Langone Health

No Placebo Group

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.

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

I am 18 years old or older.

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.

I do not have trouble swallowing or any swallowing disorders.

Treatment Details

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.

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