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SMART TRENDS Study

NCT05957406 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2025-12-22

No results posted yet for this study

Summary

A multicenter, interventional, feasibility comparison with historical controls

Conditions

  • Moderate to High-risk Noncardiac Surgery

Interventions

DEVICE

Acumen HPI Smart Alerts and Smart Trends Software

Device: Acumen HPI Smart Alerts and Smart Trends Software The Acumen HPI Smart Alerts and Smart Trends Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Smart Alerts and Smart Trends Software suite is enabled by the minimally invasive Acumen IQ sensor.

DEVICE

The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff

Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2025-10-27
Completion
2025-10-27
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 NCT05957406 on ClinicalTrials.gov