Collective Accuryn Physiologic Signals and Signatures (CAPSS)

January 11, 2021 updated by: Potrero Medical

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will comprise patients from high acuity centers such as burn, trauma, surgical, and critical care units.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiologic Changes
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Potrero Medical

Investigators

  • Principal Investigator: Eileen M Bulger, MD, University of Washington Harborview

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2020

Primary Completion (Actual)

March 29, 2020

Study Completion (Actual)

March 29, 2020

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-06-100473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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