NCT02119351|Completed
A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
ViaValve-001
A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
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ViaValve-001
A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
Sponsor study identifier
interventional
150
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 12, 2013
Actual (reported)December 2013
Actual (reported)December 2013
Actual (reported)April 21, 2014
Actual (reported)Clinical acceptability of PIVC insertion
Demonstrate non-inferiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC for ratings of clinical acceptability. Clinicians will agree or disagree that the device was clinically acceptable for the insertion.
Clinicians will provide the rating immediately after performing the insertion
Frequency of blood leakage
Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control in preventing blood leakage from the catheter hub during insertion.
Clinicians will report if blood leakage occurred immediately after the catheter insertion
Eliminating risk of blood exposure
Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC in eliminating the clinician's risk of blood exposure during the insertion process.
Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion
Insertion success
Clinicians will report if the insertion was successful immediately after performing insertion
Elimination of digital compression
Clinicians will provide the rating immediately after performing the insertion
Ease of Use
Clinicians will provide the rating immediately after performing the insertion
Insertion of the ViaValve™ Safety IV Catheter
Insertion of the ProtectIV® Plus Safety IV Catheter
Safety peripheral IV catheter with a blood control feature
Safety peripheral IV catheter with no blood control feature
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Foothills Medical Centre
Calgary, Alberta, Canada
Andrew McRae, MD, PhD
U of Calgary and Alberta Health Services
150 participants (actual enrollment reported by the registry).
First Submitted
July 12, 2013
First Posted
April 21, 2014
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
April 21, 2014
Record last verified: 2014-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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