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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Acute Kidney Injury
• Compartment Syndromes
• Critical Illness
• Intra-Abdominal Hypertension
• Sepsis
• Septic Shock

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