Non-Cardiac/ Non-Thoracic SurgeryAFMNCT03469570
Assisted Fluid Management IDE Study
A study testing EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature in people with Non-Cardiac/ Non-Thoracic Surgery and Abdominal Surgery, run by Edwards Lifesciences at 10 sites in United States.
Trial summary
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery
- What is being tested?
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Apr 2018to 25 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Be ≥ 18 years of age
- Abdominal, pelvic, major peripheral vascular surgery expected to last >2 hours post anesthesia induction
- Participate or have authorized representative participate in the Informed Consent process and sign/date the IRB approved informed consent form.
Who cannot join
- Are < 18 years of age
- Emergent or cardiovascular surgical procedure
- Are pregnant
- Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Clinical Study)
- Refusal of patient or authorized representative to sign consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The University of Texas Southwestern at Clements
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
Greenville Health System, Greenville Memorial Hospital
Greenville, South Carolina, 29605
Loma Linda Health University
Loma Linda, California, 92354
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
University of California, Davis
Sacramento, California, 95817
Stony Brook Medicine
Stony Brook, New York, 11794-8480
About this study
Official title: A Validation of the Assisted Fluid Management Feature
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
Read the detailed description
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
- Conditions
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
- Being tested
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
- Keywords
- Non-Cardiac, Non-Thoracic, Fluid Management, Perioperative Goal Directed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV1000 Clinical Platform with Assisted Fluid Management (AFM) FeatureDevice
Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
| Study group | Role | What they receive |
|---|---|---|
| Assisted Fluid Management | Experimental | Subjects enrolled in the validation study will have their fluid management decisions guided by the Acumen™ Assisted Fluid Management Feature. The Principal Investigator will accept or decline fluid recommendations. Receives: Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Assisted Fluid Management Feature
Stroke volume change meeting the clinician-selected fluid strategy
Measured: 30 Day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start19 Apr 2018
- Primary completion21 Dec 2018
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Cardiac/ Non-Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tina Abdelnour, MS, BSN, Study director, Edwards Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469570
- Sponsor's protocol ID
- 2017-011
- Acronym
- AFM
- Status last verified
- May 2019
- First submitted
- 12 Mar 2018
- Last updated
- 8 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
PubMed 18582931
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation of the Assisted Fluid Management Feature
- ClinicalTrials.gov ID
- NCT03469570
- Acronym / sponsor ID
- AFM / 2017-011
- Conditions
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
- Keywords
- Non-Cardiac, Non-Thoracic, Fluid Management, Perioperative Goal Directed Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 8 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
Detailed description
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assisted Fluid Management | Experimental | Device: EV1000 Clinical Platform with Assisted Fluid Management (AFM) FeatureSubjects enrolled in the validation study will have their fluid management decisions guided by the Acumen™ Assisted Fluid Management Feature. The Principal Investigator will accept or decline fluid recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be ≥ 18 years of age
- Abdominal, pelvic, major peripheral vascular surgery expected to last >2 hours post anesthesia induction
- Participate or have authorized representative participate in the Informed Consent process and sign/date the IRB approved informed consent form.
Key exclusion criteria (5 listed)
- Are < 18 years of age
- Emergent or cardiovascular surgical procedure
- Are pregnant
- Participation in any other drug, device, or biologic study concomitantly, or within the last 30 days (which may clinically interfere with this Clinical Study)
- Refusal of patient or authorized representative to sign consent
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 |
|---|---|---|
| EV1000 Clinical Platform with Assisted Fluid Management (AFM) FeatureSubjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature. | Device | Assisted Fluid Management |
Primary outcome
Effectiveness of the Assisted Fluid Management Feature
Time frame: 30 Day follow-up
Stroke volume change meeting the clinician-selected fluid strategy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18582931Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
- Individual participant dataSharing planned: No
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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.
Tina Abdelnour, MS, BSN study director
Edwards Lifesciences
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature in people with Non-Cardiac/ Non-Thoracic Surgery and Abdominal Surgery, run by Edwards Lifesciences at 10 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Yes. Results are posted in the registry (first posted 8 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effectiveness of the Assisted Fluid Management Feature (time frame: 30 Day follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469570, which also lists 1 linked publication.
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 8 Nov 2024.