PillSense Use in Anemia and Hemoccult

Launched by ADVENTHEALTH · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the PillSense™ capsule, which is designed to quickly check for blood in the upper digestive system. Participants will swallow this small capsule, and within about 10 minutes, it can show if there’s any bleeding. The goal of the study is to see if this test can help doctors safely determine whether patients with anemia or a positive stool test can be discharged from the hospital without needing more invasive procedures like endoscopy, which involves using a tube to look inside the digestive tract.

To be eligible for this trial, participants must be at least 18 years old, able to provide consent, and currently hospitalized for certain conditions, such as having a positive stool test for blood or anemia, without obvious signs of bleeding. However, individuals with serious health issues, certain swallowing disorders, or specific gastrointestinal conditions will not be able to participate. If you join the study, you can expect to take the PillSense™ capsule and help researchers learn more about its potential to improve patient care in the future.

Gender

ALL

Eligibility criteria

• 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