← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after endoscopy procedure
Awards & highlights

Study Summary

This trial is testing a new pill that has a built in sensor to detect if there is bleeding in the upper digestive tract. The information from the sensor is then transmitted to medical personnel.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of False negative results
Number of False positive results
Number of True negative results
+1 more

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

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
816,366 Total Patients Enrolled
Melissa Latorre, MDPrincipal InvestigatorNYU Langone Health

Media Library

HemoPill (Capsule Device) Clinical Trial Eligibility Overview. Trial Name: NCT05415124 — N/A
Upper Gastrointestinal Bleeding Research Study Groups: HemoPIll group
Upper Gastrointestinal Bleeding Clinical Trial 2023: HemoPill Highlights & Side Effects. Trial Name: NCT05415124 — N/A
HemoPill (Capsule Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415124 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants meet for eligibility in this clinical trial?

"To be accepted into this medical study, potential participants must have upper gastrointestinal bleeding and be between 18 to 99 years old. Approximately 50 people are needed for full recruitment."

Answered by AI

Does this trial have an age limit, and if so, what is the upper boundary?

"This medical trial can only be accessed by individuals aged between 18 and 99. Patients below the age of consent have access to 3 additional studies, while those over 65 are able to enroll in 27 distinct clinical trials."

Answered by AI

What is the current estimated enrollment size for this research trial?

"Affirmative. According to the clinicaltrials.gov website, this medical experiment is currently seeking new participants; it was initially published on June 17th 2022 and updated as recently as August 4th 2022. This trial seeks 50 individuals from one research site."

Answered by AI

Are there still opportunities to join this experiment?

"According to the data hosted on clinicaltrials.gov, this trial remains open for recruitment and was last updated on August 4th 2022. The initial posting date of June 17th 2022 is also noted."

Answered by AI
~15 spots leftby Dec 2024