Assessing Negative PillSense™ for Safe Discharge in Patients With Positive Hemoccult and/or Unexplained Anemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- AdventHealth
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Accuracy of Negative PillSense™ Result in Predicting Safe Discharge
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: PillSense™ (Device)
Outcomes
Primary Outcomes
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
- 30-Day Mortality(30 days post-discharge)
- False Negative Rate of PillSense™(During hospitalization (up to 72 hours after capsule ingestion))
- Timing of Endoscopic Intervention(24-72 hours)
- Length of Hospital Stay(24-72 hours)
- 30-Day Readmission Rate(30 days post-discharge)