NCT05631652

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: EnteraSense Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Gastrointestinal Bleeding

Interventions

Type	Name	Description
DEVICE	PillSense 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.

Timeline

• Start date: 2021-02-11
• Primary completion: 2021-03-11
• Completion: 2021-03-11
• First posted: 2022-11-30
• Last updated: 2022-11-30

Locations

1 site across 1 country: Czechia