NCT04669548

Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Potrero Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

Detailed description

The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiac surgical intervention(s). The secondary objective is to determine the incidence of intraoperative and postoperative intra-abdominal hypertension in the cardiovascular surgery population, analyze what factors may contribute to the development of intra-abdominal hypertension (IAH) in this patient population, and analyze associations of IAH with organ dysfunctions such as acute kidney injury and other clinical outcomes (e.g. ICU length of stay, required hemodialysis, readmission).

Conditions

• Intraabdominal Hypertension
• Abdominal Compartment Syndrome
• Acute Kidney Injury
• Cardiovascular Surgery

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: 2020-12-21
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-12-17
• Last updated: 2022-09-28

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study