Status:
ENROLLING_BY_INVITATION
PillSense Use in Anemia and Hemoccult
Lead Sponsor:
AdventHealth
Collaborating Sponsors:
EnteraSense Limited
Conditions:
Occult Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding (UGIB)
Eligibility:
All Genders
18+ years
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06951490
Start Date
May 15 2025
End Date
June 15 2027
Last Update
July 9 2025
Active Locations (1)
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1
AdventHealth Orlando
Orlando, Florida, United States, 32804