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Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial
Lukas Bajer1, Marvin Ryou2, Christopher C Thompson2
1Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
Clinical Endoscopy
|January 17, 2024
Summary
The PillSense capsule safely and effectively detected upper gastrointestinal bleeding (UGIB) in human volunteers. This novel diagnostic tool shows promise for rapid, noninvasive triage of patients with suspected UGIB.
Area of Science:
- Gastroenterology
- Medical Devices
- Diagnostic Technology
Background:
- Upper gastrointestinal bleeding (UGIB) is a common cause of hospitalization.
- Current diagnosis relies on direct visualization, often requiring invasive procedures.
Purpose of the Study:
- To evaluate the safety and feasibility of the PillSense system for in vivo UGIB detection.
- To assess the PillSense system's performance in human volunteers.
Main Methods:
- Ten volunteers ingested a PillSense capsule.
- Autologous blood preparations were administered to simulate bleeding.
- Monitoring included capsule passage, tolerability, and adverse events.
Main Results:
- The procedure was completed successfully in 90% of participants.
- The PillSense system accurately detected blood after ingestion of blood preparations.
- No adverse events were reported, and capsule passage was verified in all subjects.
Conclusions:
- The PillSense system is a feasible, safe, and well-tolerated tool for UGIB diagnosis.
- It offers a novel, noninvasive, and user-friendly triage method for suspected UGIB.
- This study supports its potential as a valuable diagnostic aid in clinical settings.
