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Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada

NCT03653572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-08-31

No results posted yet for this study

Summary

The purpose of the study is to collect images data sets from clinical cases and periodic user feedback on the Next Generation Venue ultrasound system under clinical conditions. This is a medical device study designed as a clinical, open label, unblinded, non-randomized, prospective, feasibility research study.

Conditions

  • Ultrasound Use in Emergency/Medical Care

Interventions

DEVICE

Ultrasound exam

Eligible subjects will be positioned for their ultrasound exam, which will take a similar amount of time and be performed in a similar manner as standard of care ultrasound exams at the site. The type and duration of ultrasound exam will be based on the subject's clinical condition.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Martin Girard, MD · Hopital Notre-Dame

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-14
Primary Completion
2017-08-01
Completion
2017-08-02
FDA Device
Yes

Countries

  • Canada

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 NCT03653572 on ClinicalTrials.gov