Status:
RECRUITING
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
Lead Sponsor:
Potrero Medical
Conditions:
Intraabdominal Hypertension
Abdominal Compartment Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence ...
Eligibility Criteria
Inclusion
- Signed or Verbal Informed Consent as required by IRB (if applicable).
- Adult (age ≥ 18).
- Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
- Patient is undergoing cardiac surgical intervention(s).
Exclusion
- Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73m2 within 30 days prior to procedure.
- The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution.
Key Trial Info
Start Date :
December 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT04669548
Start Date
December 21 2020
End Date
December 31 2026
Last Update
September 28 2022
Active Locations (9)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
San Francisco VA Medical Center
San Francisco, California, United States, 94121
3
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
4
Cleveland Clinic Florida
Weston, Florida, United States, 33331