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Collective Accuryn Physiologic Signals and Signatures (CAPSS)

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ClinicalTrials.gov Identifier: NCT03817281
Recruitment Status : Withdrawn (Lack of Enrollment)
First Posted : January 25, 2019
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Potrero Medical

Brief 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.

Condition or disease Intervention/treatment
Critical Illness Acute Kidney Injury Sepsis Septic Shock Abdominal Compartment Syndrome Device: Accuryn Monitoring System

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Collective Accuryn Physiologic Signals and Signatures: A Retrospective and Prospective Analysis (CAPSS Study)
Actual Study Start Date : March 29, 2020
Actual Primary Completion Date : March 29, 2020
Actual Study Completion Date : March 29, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817281


Locations
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United States, Washington
University of Washington Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Potrero Medical
Investigators
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Principal Investigator: Eileen M Bulger, MD University of Washington Harborview
Additional Information:

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Responsible Party: Potrero Medical
ClinicalTrials.gov Identifier: NCT03817281    
Other Study ID Numbers: CRD-06-100473
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Compartment Syndromes
Intra-Abdominal Hypertension
Acute Kidney Injury
Critical Illness
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pathologic Processes
Disease Attributes
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases