Venue Ultrasound Evaluation - Israel

NCT03861663 | Completed

• 1 other identifier: 110.04-2016-GES-0008
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ultrasound Exam in Emergency/Medical 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 (Clinician User Preference Survey) from device users on device performance for quality optimization. The feedback will not be aggregated or statistically analyzed. The scale is a 1-5 Likert score (1 - Poor, 2 - Needs Improvement, 3 - As expected/Equal, 4 - Better then expected, 5 - Excellent) There is no total score.

  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

Interventions

Ultrasound 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.

Eligible Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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);
• 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;
• Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.

Sponsors & Collaborators

• GE Healthcare: lead
• Rambam Health Care Campus: collaborator

Study Sites (1)

Rambam Health Care Center

Haifa, 3109601, Israel

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

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

Model Details: Device evaluation - feasibility

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 4, 2019
• Study Start: December 1, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 29, 2018
• Last Updated: March 4, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)