Collective Accuryn Physiologic Signals and Signatures

Withdrawn

• Conditions: Critical Illness; Acute Kidney Injury; Sepsis; Septic Shock; Abdominal Compartment Syndrome
• Interventions: Device: Accuryn Monitoring System

• Registration Number: NCT03817281
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Study Start: 2020-03-29
• Primary Completion: 2020-03-29
• Study Completion: 2020-03-29
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Accuryn Monitoring System	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.

Primary Outcome Measures

Name	Time	Method
Physiologic Changes	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.

Trial Locations

Locations (1)

University of Washington Harborview Medical Center; 🇺🇸 Seattle, Washington, United States