CAPSS: Collective Accuryn Physiologic Signals and Signatures

• Sponsor: Potrero Medical (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT03817281
• Collaborator: (none)
• Enrollment: 0
• Location: 1

Study Details

Study Description

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	Phase
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.

Study Design

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

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Potrero Medical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Potrero Medical
• ClinicalTrials.gov Identifier: NCT03817281
• Other Study ID Numbers: CRD-06-100473
• First Posted: Jan 25, 2019
• Last Update Posted: Jan 13, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Compartment Syndromes; Intra-Abdominal Hypertension; Acute Kidney Injury; Critical Illness

Study Results

No Results Posted as of Jan 13, 2021