Occult Gastrointestinal Bleeding, Upper Gastrointestinal Bleeding (UGIB)
Conditions
Keywords
PillSense, Upper Gastrointestinal Bleeding, GI Bleed Detection, Positive Hemoccult, Capsule Endoscopy, Non-invasive Diagnostics, Real-time GI Bleed Detection
Brief 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.
Interventions
DEVICEPillSense™
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
AdventHealth
EnteraSense Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Negative PillSense™ Result in Predicting Safe Discharge | 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
| Measure | Time frame | Description |
|---|---|---|
| False Negative Rate of PillSense™ | 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. |
| Timing of Endoscopic Intervention | 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. |
| Length of Hospital Stay | 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. |
| 30-Day Readmission Rate | 30 days post-discharge | Rate of readmission within 30 days post-discharge between patients with positive and negative PillSense™ results. |
| 30-Day Mortality | 30 days post-discharge | All-cause mortality rate between patients with positive and negative PillSense™ results. |
Countries
United States
Outcome results
None listed