Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study

Study Overview
=================
Brief Summary
-----------------
The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.

Detailed Description
-----------------
A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a peripheral vein. The PillSense result (blood detected or  blood not detected) was recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes from the ingestion of both mixtures containing blood. Subjects were followed-up for capsule passing.

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

Conditions
-----------------
Upper Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Device: PillSense System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 -60 years Ability to give written informed consent 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 Presence of pacemaker or other implantable electronic 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) Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation Active psychological issues preventing participation Stomach bezoar History of severe esophagitis 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
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>All subjects were asked to swallow a PillSense Capsule, followed by the ingestion of autologous blood mixed with water, to verify the ability of the PillSense System to correctly identify blood. | Device: PillSense System<br>* The device is composed of an orally ingested PillSense capsule and a wireless handheld PillSense receiver for real-time display of sensor data. The capsule contains an optical sensor for in-vivo detection of blood. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device ability to detect the absence of blood | Number of subjects in which PillSense capsule was able to identify the absence of blood post capsule ingestion and transmit the results to PillSense Receiver | within 30 minutes | 
| Device ability to detect the presence of blood | Number of subjects in which PillSense Capsule was able to identify the presence of blood post ingestion of a mixture containing autologous blood and transmit the results to PillSense Receiver | within 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to ingest the capsule | Number of subjects that were able to ingest the capsule | within 30 minutes | 
| Absence of device-related adverse event | Number of subject that were able to naturally pass the capsule. | up to 4 weeks | 
| Absence of device-related adverse event | Number of subject that presented device-related adverse events (e.g. capsule retention, aspiration or bowel obstruction) | up to 4 weeks |