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NCT03817281 Clinical Trial

Collective Accuryn Physiologic Signals and Signatures

Sepsis Clinical Trial

— CAPSS  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03817281
Other study ID # CRD-06-100473
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 29, 2020
Est. completion date March 29, 2020

Study information
Verified date January 2021
Source Potrero Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 29, 2020
Est. primary completion date March 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. Exclusion Criteria: 1. In the opinion of the investigator, the patient is unsuitable for the study.

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Washington Harborview Medical Center Seattle Washington

Sponsors (1)
Lead Sponsor Collaborator
Potrero Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physiologic Changes Track and analyze changes in physiologic data streams captured using the Accuryn Monitoring System to identify clinical signatures that may enable earlier diagnosis and effective intervention of critical conditions. Potential examples include AKI, sepsis/septic shock, ACS, and optimization of fluid resuscitation. 30 days
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