Collective Accuryn Physiologic Signals and Signatures

NCT03817281 | Withdrawn FDA Device

• 1 other identifier: CRD-06-100473
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Acute Kidney Injury; Sepsis; Septic Shock; Abdominal Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Accuryn Monitoring System 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.

Accuryn Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \. In the opinion of the investigator, the patient is unsuitable for the study.

Sponsors & Collaborators

• Potrero Medical: lead

Study Sites (1)

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury; Sepsis; Shock, Septic; Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eileen M Bulger, MD

  University of Washington Harborview

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: March 29, 2020
• Primary Completion: March 29, 2020
• Study Completion: March 29, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Locations

US (1)