PillSense Use in Anemia and Hemoccult

NCT06951490 | Enrolling By Invitation FDA Device

• 1 other identifier: 2232176
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Occult Gastrointestinal Bleeding; Upper Gastrointestinal Bleeding (UGIB)

Keywords

PillSense; Upper Gastrointestinal Bleeding; GI Bleed Detection; Positive Hemoccult; Capsule Endoscopy; Non-invasive Diagnostics; Real-time GI Bleed Detection

Outcome Measures

Primary Outcomes (1)

• Accuracy of Negative PillSense™ Result in Predicting Safe Discharge

  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.

  24 hours

Secondary Outcomes (5)

• 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

• 30-Day Mortality

  30 days post-discharge

Study Arms (1)

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.

Device: PillSense™

Interventions

PillSense™ DEVICE

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.

Hospitalized Patients Undergoing PillSense™ Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of hospitalized adult patients who have been referred to the gastroenterology service for evaluation of unexplained anemia and/or a positive fecal occult blood test (hemoccult) in the absence of overt gastrointestinal bleeding. These patients represent a group commonly subjected to diagnostic endoscopy despite the often-low diagnostic yield of such procedures.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead
• EnteraSense Limited: collaborator

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Related Publications (14)

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• Akiki K, Mahmoud T, Alqaisieh MH, Sayegh LN, Lescalleet KE, Abu Dayyeh BK, Wong Kee Song LM, Larson MV, Bruining DH, Coelho-Prabhu N, Buttar NS, Sedlack RE, Chandrasekhara V, Leggett CL, Law RJ, Rajan E, Gleeson FC, Alexander JA, Storm AC. A novel blood-sensing capsule for rapid detection of upper GI bleeding: a prospective clinical trial. Gastrointest Endosc. 2024 May;99(5):712-720. doi: 10.1016/j.gie.2023.11.051. Epub 2023 Dec 6.

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  BACKGROUND

• Barakat M, Aloreidi K, Gujjula S, et al. Overutilization of Fecal Occult Blood Test in the Acute Hospital Setting and its Impact on Clinical Management and Outcomes. Gastroenterology. 2020;159(2):e21-e22. doi:10.1053/j.gastro.2020.06.059

  BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: April 27, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)