An observational study in Occult Gastrointestinal Bleeding and Upper Gastrointestinal Bleeding (UGIB), sponsored by AdventHealth. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by AdventHealth · Observational
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 20 is below the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →AdventHealth is the lead sponsor of 107 studies on the registry; 25 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
Systolic blood pressure \< 90 mm Hg Pulse > 120 bpm
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
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.
Accuracy of Negative PillSense™ Result in Predicting Safe Discharge
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.
Time frame: 24 hours
False Negative Rate of PillSense™
Rate at which a negative PillSense™ results fail to detect clinically significant upper gastrointestinal bleeding later confirmed by endoscopy.
Time frame: During hospitalization (up to 72 hours after capsule ingestion)
Timing of Endoscopic Intervention
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.
Time frame: 24-72 hours
Length of Hospital Stay
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.
Time frame: 24-72 hours
30-Day Readmission Rate
Rate of readmission within 30 days post-discharge between patients with positive and negative PillSense™ results.
Time frame: 30 days post-discharge
30-Day Mortality
All-cause mortality rate between patients with positive and negative PillSense™ results.
Time frame: 30 days post-discharge
Plan to share: No — We will not be sharing information from this study.
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