Collective Accuryn Physiologic Signals and Signatures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-29

Study Completion Date

2020-03-29

Brief Summary

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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.

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Detailed Description

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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

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Critical Illness Acute Kidney Injury Sepsis Septic Shock Abdominal Compartment Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Accuryn Monitoring System

Observational only (no intervention). Study Cohort is patients using the Accuryn Monitoring System as a standard-of-care digital urimeter, during their standard course of treatment.

Accuryn Monitoring System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Received Accuryn Monitoring System during hospital stay.
2. Diagnosed with or developed one or more of the targeted conditions while connected to the Accuryn Monitoring System.