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enFlow IV Fluid and Blood Warming System

NCT04709627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-07-01

No results posted yet for this study

Summary

This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an element of maintaining acceptable core temperatures.

Conditions

  • Hypothermia; Anesthesia

Interventions

DEVICE

enFlow IV Fluid and Blood Warming System

The enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Vyaire Medical

    lead INDUSTRY

Principal Investigators

  • Mikko Lax, MD · Helsinki and Uusimaa Hospital District, Helsinki University Hospital

  • Seppo Mustola, MD, PhD · South Karelia Central Hospital (EKSOTE, ALTEK), Dept. of Anesthesiology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-06
Primary Completion
2022-02-23
Completion
2022-02-23
FDA Device
Yes

Countries

  • Finland

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 NCT04709627 on ClinicalTrials.gov