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

Upper Gastrointestinal Bleeding Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05631652
Study type Interventional
Source EnteraSense Limited
Contact
Status Completed
Phase N/A
Start date February 11, 2021
Completion date March 11, 2021
View Details
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