Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

Part of paid clinical trials in Los Angeles, California.

Sponsor
Potrero Medical
Study ID
NCT04669548
Status
Recruiting
Apply to this trial

Conditions

  • Abdominal Compartment Syndrome
  • Acute Kidney Injury
  • Cardiovascular Surgery
  • Intraabdominal Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

Key Dates

Start date
Dec 21, 2020
Status verified
Sep 2022
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
2,500 participants (estimated)

Arms

  • Arm: Accuryn Monitoring System
    Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay

Primary Outcome Measure

Urine Output (UO) [ Time Frame: 30 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
San Francisco VA Medical CenterSan FranciscoCalifornia94121-
George Washington University HospitalWashington D.C.District of Columbia20037
Gage Parr, MD
[email protected]
202-715-4000
Gage Parr, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FloridaWestonFlorida33331
Steven Minear, MD
[email protected]
954-290-1569
Camila Teixeira, MD
[email protected]
954-909-1025
Steven Minear, MD (PRINCIPAL_INVESTIGATOR)
Jewish Hospital / University of LouisvilleLouisvilleKentucky40202
Terry Blanton, BSN, RN
[email protected]
502-587-4381
Shavonne Silvers, LPN
[email protected]
5026815171
Jiapeng Huang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mission Health HospitalAshevilleNorth Carolina28803
Leslie McPeters, MSN, FNP
[email protected]
828-213-5679
Lynne Hampton, MBA, RN
[email protected]
828.213.5631
Mark Groh, MD (PRINCIPAL_INVESTIGATOR)
Duke University HospitalDurhamNorth Carolina27710
Madhav Swaminathan, MD
[email protected]
919-681-6532
Madhav Swaminathan, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Cleveland ClinicClevelandOhio44195
Michael Kot, MD
[email protected]
216-442-6616
Michael Kot, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CASan Francisco VA Medical Center· San Francisco, CAGeorge Washington University Hospital· Washington D.C., DCCleveland Clinic Florida· Weston, FLJewish Hospital / University of Louisville· Louisville, KYMission Health Hospital· Asheville, NC

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