Critical IllnessCAPSSNCT03817281
Collective Accuryn Physiologic Signals and Signatures
An observational study of Critical Illness and Acute Kidney Injury, run by Potrero Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Kidney Injury, Sepsis
- What is being tested?
- Accuryn Monitoring System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2020to 29 Mar 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise patients from high acuity centers such as burn, trauma, surgical, and critical care units.
Who may be able to join
- Received Accuryn Monitoring System during hospital stay.
- Diagnosed with or developed one or more of the targeted conditions while connected to the Accuryn Monitoring System.
Who cannot join
- 1. In the opinion of the investigator, the patient is unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Collective Accuryn Physiologic Signals and Signatures: A Retrospective and Prospective Analysis (CAPSS Study)
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.
Read the 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.
- Conditions
- Critical Illness, Acute Kidney Injury, Sepsis, Septic Shock, Abdominal Compartment Syndrome
- Being tested
- Accuryn Monitoring System
- Medical subject headings
- Critical Illness, Acute Kidney Injury, Sepsis, Shock, Septic, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuryn Monitoring SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accuryn Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Changes
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start29 Mar 2020
- Primary completion29 Mar 2020
- Study completion29 Mar 2020
Why it stopped: Lack of Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Potrero Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eileen M Bulger, MD, Principal investigator, University of Washington Harborview
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817281
- Sponsor's protocol ID
- CRD-06-100473
- Acronym
- CAPSS
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collective Accuryn Physiologic Signals and Signatures: A Retrospective and Prospective Analysis (CAPSS Study)
- ClinicalTrials.gov ID
- NCT03817281
- Acronym / sponsor ID
- CAPSS / CRD-06-100473
- Conditions
- Critical Illness, Acute Kidney Injury, Sepsis, Septic Shock, Abdominal Compartment Syndrome
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of Enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Potrero MedicalIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2020 (actual)
- Primary completion
- 29 Mar 2020 (actual)
- Study completion
- 29 Mar 2020 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuryn Monitoring System | – | Device: Accuryn Monitoring SystemObservational 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise patients from high acuity centers such as burn, trauma, surgical, and critical care units.
Key inclusion criteria (2 listed)
- Received Accuryn Monitoring System during hospital stay.
- Diagnosed with or developed one or more of the targeted conditions while connected to the Accuryn Monitoring System.
Key exclusion criteria (1 listed)
- 1. In the opinion of the investigator, the patient is unsuitable for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuryn Monitoring SystemThe 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. | Device | Accuryn Monitoring System |
Primary outcome
Physiologic Changes
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen M Bulger, MD principal investigator
University of Washington Harborview
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Acute Kidney Injury, run by Potrero Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic Changes (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.