Upper Gastrointestinal Bleeding
Conditions
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.
Interventions
DEVICEPillSense System
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.
Sponsors
EnteraSense Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 -60 years 2. Ability to give written informed consent
Exclusion criteria
1. Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure \<100 mmHg,heart rate \> 100 / min) 2. Known current stenosis of the GI tract 3. Presence of pacemaker or other implantable electronic device 4. Dysphagia or difficulties in swallowing pills the size of the capsule 5. History of achalasia or known esophageal dysmotility 6. History of gastroparesis 7. History of severe constipation (1 bowel movement per week or less) 8. Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation 9. Active psychological issues preventing participation 10. Stomach bezoar 11. History of severe esophagitis 12. History of Crohn disease 13. History of diverticulitis 14. History of bowel obstruction 15. Suspected gastrointestinal tumor disease 16. Planned MRI investigation (MRI needed before the capsule is excreted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device ability to detect the absence of blood | within 30 minutes | 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 |
| Device ability to detect the presence of blood | within 30 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to ingest the capsule | within 30 minutes | Number of subjects that were able to ingest the capsule |
| Absence of device-related adverse event | up to 4 weeks | Number of subject that were able to naturally pass the capsule. |
Countries
Czechia
Outcome results
None listed