Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06951490

PillSense Use in Anemia and Hemoccult

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Occult Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Upper Gastrointestinal Bleeding (UGIB)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 30-Day Mortality

    Time frame: 30 days post-discharge

    All-cause mortality rate between patients with positive and negative PillSense™ results.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • EnteraSense Limited

Registry information

Official study title

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

Acronym: PillSense™

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.