PillSense Use in Anemia and Hemoccult

Conditions

• Occult Gastrointestinal Bleeding
• Upper Gastrointestinal Bleeding (UGIB)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PillSense™ — DEVICE
  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.

Study Details

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.

Key Dates

Start date

May 15, 2025

Status verified

Apr 2025

Primary completion

May 14, 2026

Completion

Jun 15, 2027

Study Design

Enrollment

20 participants (estimated)

Arms

• Arm: Hospitalized Patients Undergoing PillSense™ Testing
  This group includes hospitalized adult patients who have been referred to gastroenterology services for unexplained anemia and/or a positive fecal occult blood test (hemoccult) in the absence of overt gastrointestinal bleeding (e.g., no melena, hematemesis, or hematochezia). All participants will ingest the PillSense™ capsule.

Primary Outcome Measure

Accuracy of Negative PillSense™ Result in Predicting Safe Discharge [ Time Frame: 24 hours ]

Locations (1)

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