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PillSense Use in Anemia and Hemoccult

NCT06951490 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-27

No results posted yet for this study

Summary

In this study, participants will be offered a PillSense™ capsule, a small capsule to swallow, which can detect the presence of blood in the upper digestive tract within about 10 minutes. The results of this capsule test will not alter the current care plan but will help us assess whether PillSense™ can be used in the future as a standalone test to determine if it is safe for patients to be discharged with anemia or a positive stool test without other signs of gastrointestinal bleeding. This study aims to collect data that will help determine if the PillSense™ capsule could one day reduce the need for more invasive procedures while hospitalized, like endoscopy, and ensure safe patient discharge.

Conditions

  • Occult Gastrointestinal Bleeding
  • Upper Gastrointestinal Bleeding (UGIB)

Interventions

DEVICE

PillSense™

The PillSense™ System is a prescription only device consisting of a reusable receiver and single-use ingestible capsule, intended to be used for the detection of blood in the upper gastrointestinal tract.

Sponsors & Collaborators

  • EnteraSense Limited

    collaborator INDUSTRY

  • AdventHealth

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-05-14
Completion
2027-06-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951490 on ClinicalTrials.gov