PillSense Use in Anemia and Hemoccult (PillSense™)

April 23, 2026 updated by: AdventHealth

Assessing Negative PillSense™ for Safe Discharge in Patients With Positive Hemoccult and/or Unexplained Anemia

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of hospitalized adult patients who have been referred to the gastroenterology service for evaluation of unexplained anemia and/or a positive fecal occult blood test (hemoccult) in the absence of overt gastrointestinal bleeding. These patients represent a group commonly subjected to diagnostic endoscopy despite the often-low diagnostic yield of such procedures.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Able to provide informed consent
  • Hospitalized patients who have been referred to the gastroenterology service for:

A positive hemoccult (fecal occult blood test) and/or Anemia, In the absence of overt gastrointestinal bleeding - Overt gastrointestinal bleeding is defined as the presence of: Melena (black, tarry stools) Hematochezia (bright red blood per rectum) Hematemesis (vomiting blood)

Exclusion Criteria:

  • Hemodynamic instability, defined as:

Systolic blood pressure < 90 mm Hg Pulse > 120 bpm

  • Presence of overt gastrointestinal bleeding (melena, hematochezia, or hematemesis)
  • Conditions that might contraindicate use of an ingestible capsule, such as:

Dysphagia or odynophagia Swallowing disorder Altered mental status Zenker's diverticulum Crohn's disease Previous GI surgery Suspected ileus or bowel obstruction GI perforation GI motility disorders (e.g., esophageal dysmotility, gastroparesis)

- Known upper GI pathology, such as: Esophageal or gastric cancer Recent upper GI ulcer bleeding (within 3 months) Recent upper GI procedures or surgeries

  • Presence of a cardiac implantable electronic device (CIED)
  • Pregnant or lactating women
  • Planned MRI before capsule excretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Negative PillSense™ Result in Predicting Safe Discharge
Time Frame: 24 hours
To measure the percentage of participants with a negative Pillsense™ result who are safely discharged from the hospital without requiring urgent endoscopic intervention or experiencing adverse events during their hospitalization.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
False Negative Rate of PillSense™
Time Frame: During hospitalization (up to 72 hours after capsule ingestion)
Rate at which a negative PillSense™ results fail to detect clinically significant upper gastrointestinal bleeding later confirmed by endoscopy.
During hospitalization (up to 72 hours after capsule ingestion)
Timing of Endoscopic Intervention
Time Frame: 24-72 hours
The average number of hours between taking the PillSense capsule and having an upper endoscopy, compared between patients with positive and negative PillSense results, to see if test results affect how quickly endoscopy is done.
24-72 hours
Length of Hospital Stay
Time Frame: 24-72 hours
Measure the average hospital length of stay (in days) between patients with positive and negative PillSense™ results to evaluate whether test outcome is associated with differences in duration of hospitalization.
24-72 hours
30-Day Readmission Rate
Time Frame: 30 days post-discharge
Rate of readmission within 30 days post-discharge between patients with positive and negative PillSense™ results.
30 days post-discharge
30-Day Mortality
Time Frame: 30 days post-discharge
All-cause mortality rate between patients with positive and negative PillSense™ results.
30 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Collaborators

EnteraSense Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

May 14, 2026

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2232176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not be sharing information from this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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