Venue Ultrasound Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-01-29

Brief Summary

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The study purpose is to collect images and user feedback from the Next Generation Venue Ultrasound system, components, and accessories under clinical conditions, as required for device development and optimization.

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Detailed Description

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Adult patients (aged \>18 years) will be enrolled that present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), US unit, and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. If a subject has a clinical indication for ultrasound exam, the routine exam will be performed with the standard equipment, and an additional exam will be performed using the investigational ultrasound device.

Conditions

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Ultrasound Exam in Emergency/Medical Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Device evaluation - feasibility

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Eligible Subjects

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

Group Type OTHER

Ultrasound

Intervention Type DEVICE

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.

Interventions

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Ultrasound

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No