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Assisted Fluid Management IDE Study

NCT03469570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2024-11-08

Study results available
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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.

Conditions

  • Non-Cardiac/ Non-Thoracic Surgery
  • Abdominal Surgery
  • Pelvic Surgery
  • Major Peripheral Vascular Surgery

Interventions

DEVICE

EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature

Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Tina Abdelnour, MS, BSN · Edwards Lifesciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2018-12-21
Completion
2019-01-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03469570 on ClinicalTrials.gov