NCT03653572

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

January 22, 2018

Last Update Submit

August 28, 2018

Conditions

Ultrasound Use in Emergency/Medical Care

Keywords

UltrasoundEmergency care

Outcome Measures

Primary Outcomes (2)

  • Obtain Image sets using Ultrasound Venue System

    Number of representative image sets for subjects enrolled in study

    Two months

  • Periodic user feedback

    Periodic user feedback data from device users.

    Two months

Study Arms (1)

Eligible Subjects

OTHER

All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.

Device: Ultrasound exam

Interventions

Ultrasound examDEVICE

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.

Eligible Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (aged 18 years of age or older) at the time of consent;
  • Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning); AND
  • Able and willing to provide written informed consent for participation.

You may not qualify if:

  • Are pregnant subjects;
  • Require procedures that cannot be readily completed using available investigational devices; OR
  • Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Study Officials

  • Martin Girard, MD

    Hopital Notre-Dame

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

August 31, 2018

Study Start

June 14, 2017

Primary Completion

August 1, 2017

Study Completion

August 2, 2017

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

CA(1)