NCT04669548 · Potrero Medical
Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
What this study is about
The Accuryn Registry Study is an open-ended, global, multi-center, reviewing past data and forward-looking, single-treatment group$1 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Los Angeles, California
- San Francisco, California
- Washington D.C., District of Columbia
- Weston, Florida
- Louisville, Kentucky
- Asheville, North Carolina
- Durham, North Carolina
- Winston-Salem, North Carolina
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 28, 2022 · Source of record for eligibility and locations