NCT05385224

PillSense System for Detecting UGI Bleed

A Clinical Study to Evaluate Effectiveness and Safety of the PillSense System in Detecting Blood in the Stomach for the Evaluation of Upper Gastrointestinal Bleeding (UGIB)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: EnteraSense Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• UGI Bleed
• Upper Gastrointestinal Bleeding
• Upper Gastrointestinal Bleed

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PillSense	The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.

Timeline

• Start date: 2021-12-10
• Primary completion: 2022-09-07
• Completion: 2022-09-13
• First posted: 2022-05-23
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study