NCT03817281

Collective Accuryn Physiologic Signals and Signatures

Collective Accuryn Physiologic Signals and Signatures: A Retrospective and Prospective Analysis (CAPSS Study)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Potrero Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data collection study with an FDA cleared device. Physiologic data measurements will be collected from enrolled subjects using electronic health records and data streams via the Accuryn Monitoring System. Analysis of these data has the potential to be able to acutely guide resuscitation and monitor trends for emerging critical conditions.

Detailed description

The primary objective of the CAPSS Study is to track and analyze changes in physiologic data streams to identify clinical signatures that may enable earlier diagnosis of, and effective intervention in, critical conditions.

Conditions

• Critical Illness
• Acute Kidney Injury
• Sepsis
• Septic Shock
• Abdominal Compartment Syndrome

Interventions

Type	Name	Description
DEVICE	Accuryn Monitoring System	The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.

Timeline

• Start date: 2020-03-29
• Primary completion: 2020-03-29
• Completion: 2020-03-29
• First posted: 2019-01-25
• Last updated: 2021-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study