NCT03469570

Assisted Fluid Management IDE Study

A Validation of the Assisted Fluid Management Feature

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-19
• Primary completion: 2018-12-21
• Completion: 2019-01-25
• First posted: 2018-03-19
• Last updated: 2024-11-08
• Results posted: 2024-11-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study