PillSense System for Detecting UGI Bleed

Status Completed

Clinical Trial Summary

This is a prospective, non-randomized, open-label clinical investigation to evaluate feasibility, effectiveness and safety of the PillSense System, the transit of the PillSense Capsule through the GI tract, patient tolerability of the PillSense Capsule, and blood detection.

Clinical Trial Description

Patient eligibility as set out in the inclusion/exclusion criteria for the clinical investigation will be reviewed prior to study enrollment. Prior to administering the PillSense Capsule, the PillSense Receiver will be paired with the PillSense Capsule. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message "Blood detected" or "No Blood detected". The overall investigation from the PillSense Capsule activation and ingestion until the result message is displayed takes less than 10 minutes. Esophagogastroduodenoscopy (EGD) should be completed immediately or up to 4 hours after PillSense Capsule administration in each patient that receives a "Blood detected" or "No blood detected" result to confirm the result achieved with the PillSense System. The endoscopy will be conducted according to the site's standard of care. Prior to discharge each patient will undergo an X-Ray examination to evaluate for PillSense Capsule presence. Following discharge, if there is no verifiable evidence that the PillSense Capsule passed through the gastrointestinal tract (GIT) (such as a photograph of stool with capsule in it or photograph of the capsule alone), the patient may undergo an X-Ray examination at Day 7 ± 5 days and, if necessary, at Day 14± 7 days to ascertain the passage status of the PillSense Capsule. If the PillSense Capsule did not pass through the GIT, it should be removed by an endoscopic method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05385224
Study type	Interventional
Source	EnteraSense Limited
Contact
Status	Completed
Phase	N/A
Start date	December 10, 2021
Completion date	September 13, 2022

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