Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada
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|ClinicalTrials.gov Identifier: NCT03653572|
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ultrasound Use in Emergency/Medical Care||Device: Ultrasound exam||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada|
|Actual Study Start Date :||June 14, 2017|
|Actual Primary Completion Date :||August 1, 2017|
|Actual Study Completion Date :||August 2, 2017|
All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.
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.
- Obtain Image sets using Ultrasound Venue System [ Time Frame: Two months ]Number of representative image sets for subjects enrolled in study
- Periodic user feedback [ Time Frame: Two months ]Periodic user feedback data from device users.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653572
|Montréal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||Martin Girard, MD||Hopital Notre-Dame|