NCT04669548 Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry
| NCT ID | NCT04669548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Potrero Medical |
| Condition | Intraabdominal Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2020-12-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2020-12-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.
Eligibility Criteria
Inclusion Criteria: 1. Signed or Verbal Informed Consent as required by IRB (if applicable). 2. Adult (age ≥ 18). 3. Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment). 4. Patient is undergoing cardiac surgical intervention(s). Exclusion Criteria: 1. 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. 2. 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.
Contact & Investigator
Vanessa Moll, MD, PhD
STUDY DIRECTOR
Potrero Medical
Frequently Asked Questions
Who can join the NCT04669548 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intraabdominal Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04669548 currently recruiting?
Yes, NCT04669548 is actively recruiting participants. Contact the research team at bblackwell@potreromed.com for enrollment information.
Where is the NCT04669548 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Francisco, United States, Washington D.C., United States, Weston, United States and 5 additional locations.
Who is sponsoring the NCT04669548 clinical trial?
NCT04669548 is sponsored by Potrero Medical. The principal investigator is Vanessa Moll, MD, PhD at Potrero Medical. The trial plans to enroll 2,500 participants.