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The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PillSense System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillSense System | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut klinické a experimentálnà medicÃny (IKEM), | Prague | Czechia |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |