Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study

Study Overview
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Brief Summary
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This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).

Detailed Description
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The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is a handheld device which displays real-time information gathered from the capsule and clearly displays results, Blood Detected or No Blood Detected. All enrolled participants were admitted for suspected UGIB and were required to ingest a PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule evaluation and results were compared with the PillSense System result, i.e., Blood Detected or No Blood Detected. The study was also designed to confirm transit of the PillSense Capsule through the GI tract and patient tolerability of the PillSense Capsule.

Official Title
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Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study

Conditions
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Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Device: PillSense System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 -80 years Ability to give written informed consent Clinical suspicion of bleeding Exclusion Criteria: Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure <100 mmHg,heart rate > 100 / min) Known current stenosis of the GI tract Subject is using a pacemaker or other implantable electrical device Dysphagia or difficulties in swallowing pills the size of the capsule History of achalasia or known esophageal dysmotility History of gastroparesis History of severe constipation (1 bowel movement per week or less) Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation Presence of psychological issues preventing participation Stomach bezoar History of Crohn disease History of diverticulitis History of bowel obstruction Suspected gastrointestinal tumor disease Planned MRI investigation (MRI needed before the capsule is excreted)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PillSense System<br>The device is composed of an orally ingested sensor capsule and a wireless handheld receiver for real-time display of sensor data. The capsule contains a measuring slot for blood entry. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract. | Device: PillSense System<br>* The PillSense capsule is a diagnostic capsule equipped with a sensor for in vivo detection of liquid blood and a paired PillSense receiver for result display.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device feasibility | Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver | within 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device sensitivity | Subjects with positive findings for blood based on PillSense and EGD | within 2 hours | 
| Device Specificity | Subjects with negative findings for blood based on PillSense and EGD | within 2 hours | 
| Safety | Number of patients that developed device-related adverse event (etc. retention, aspiration or bowel obstruction) | up to 3 weeks |