PillSense Use in Anemia and Hemoccult (PillSense™)

AdventHealth

Status: Invitation-only

Conditions: Upper Gastrointestinal Bleeding (UGIB); Occult Gastrointestinal Bleeding

Treatments: Device: PillSense™

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06951490

2232176

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Hospitalized Patients Undergoing PillSense™ Testing

Description:

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.

Treatment:

Device: PillSense™