Upper Gastrointestinal Bleeding
Conditions
Brief summary
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
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.
Interventions
DEVICEPillSense System
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.
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 -80 years * Ability to give written informed consent * Clinical suspicion of bleeding
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. Subject is using a pacemaker or other implantable electrical 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. Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation 9. Presence of psychological issues preventing participation 10. Stomach bezoar 11. History of Crohn disease 12. History of diverticulitis 13. History of bowel obstruction 14. Suspected gastrointestinal tumor disease 15. Planned MRI investigation (MRI needed before the capsule is excreted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device feasibility | within 30 minutes | Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device sensitivity | within 2 hours | Subjects with positive findings for blood based on PillSense and EGD |
| Device Specificity | within 2 hours | Subjects with negative findings for blood based on PillSense and EGD |
| Safety | up to 3 weeks | Number of patients that developed device-related adverse event (etc. retention, aspiration or bowel obstruction) |
Countries
Czechia
Outcome results
None listed