Peripheral Intravenous CatheterViaValve-001NCT02119351
A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
A study testing ViaValve™ Safety IV Catheter and ProtectIV® Plus Safety IV Catheter in people with Peripheral Intravenous Catheter, run by Smiths Medical, ASD, Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Intravenous Catheter
- What is being tested?
- ViaValve™ Safety IV Catheter and ProtectIV® Plus Safety IV Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment.
- Willing and able to sign an Informed Consent (patient or legally authorized representative).
Who cannot join
- Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter.
- Fluid to be infused is not appropriate for peripheral intravenous catheters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
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.
- Conditions
- Peripheral Intravenous Catheter
- Being tested
- ViaValve™ Safety IV Catheter, ProtectIV® Plus Safety IV Catheter
- Keywords
- peripheral intravenous catheters, blood exposure, blood control, IV catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViaValve™ Safety IV CatheterDevice
Safety peripheral IV catheter with a blood control feature
ProtectIV® Plus Safety IV CatheterDevice
Safety peripheral IV catheter with no blood control feature
| Study group | Role | What they receive |
|---|---|---|
| ViaValve™ Safety IV Catheter | Active comparator | Insertion of the ViaValve™ Safety IV Catheter Receives: Device: ViaValve™ Safety IV Catheter |
| ProtectIV® Plus Safety IV Catheter | Active comparator | Insertion of the ProtectIV® Plus Safety IV Catheter Receives: Device: ProtectIV® Plus Safety IV Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion
Secondary outcomes (3)
Insertion success
Demonstrate the insertion success rate of the ViaValve™ I.V. Catheter is non-inferior to the control PIVC. Insertion success defined as a catheter confirmed successfully placed within the selected vessel in 3 or fewer venipuncture attempts.
Measured: Clinicians will report if the insertion was successful immediately after performing insertion
Elimination of digital compression
Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in eliminating the clinician's need to use digital compression during the insertion process. Clinicians will agree or disagree the device eliminates the need for digital compression after each PIVC insertion.
Measured: Clinicians will provide the rating immediately after performing the insertion
Ease of Use
Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in seven measures of ease of use. Clinicians will agree or disagree with seven statements regarding ease of use/clinical utility.
Measured: Clinicians will provide the rating immediately after performing the insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smiths Medical, ASD, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew McRae, MD, PhD, Principal investigator, U of Calgary and Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119351
- Sponsor's protocol ID
- ViaValve Study
- Acronym
- ViaValve-001
- Status last verified
- Apr 2014
- First submitted
- 12 Jul 2013
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter
- ClinicalTrials.gov ID
- NCT02119351
- Acronym / sponsor ID
- ViaValve-001 / ViaValve Study
- Conditions
- Peripheral Intravenous Catheter
- Keywords
- peripheral intravenous catheters, blood exposure, blood control, IV catheter insertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Smiths Medical, ASD, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViaValve™ Safety IV Catheter | Active comparator | Device: ViaValve™ Safety IV CatheterInsertion of the ViaValve™ Safety IV Catheter |
| ProtectIV® Plus Safety IV Catheter | Active comparator | Device: ProtectIV® Plus Safety IV CatheterInsertion of the ProtectIV® Plus Safety IV Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment.
- Willing and able to sign an Informed Consent (patient or legally authorized representative).
Key exclusion criteria (2 listed)
- Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter.
- Fluid to be infused is not appropriate for peripheral intravenous catheters.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViaValve™ Safety IV CatheterSafety peripheral IV catheter with a blood control feature | Device | ViaValve™ Safety IV Catheter |
| ProtectIV® Plus Safety IV CatheterSafety peripheral IV catheter with no blood control feature | Device | ProtectIV® Plus Safety IV Catheter |
Primary outcome
Clinical acceptability of PIVC insertion
Time frame: Clinicians will provide the rating immediately after performing the 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.
Frequency of blood leakage
Time frame: Clinicians will report if blood leakage occurred immediately after the catheter insertion
Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control in preventing blood leakage from the catheter hub during insertion.
Eliminating risk of blood exposure
Time frame: Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion
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.
3 secondary outcomes
Insertion success
Time frame: Clinicians will report if the insertion was successful immediately after performing insertion
Elimination of digital compression
Time frame: Clinicians will provide the rating immediately after performing the insertion
Ease of Use
Time frame: Clinicians will provide the rating immediately after performing the insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew McRae, MD, PhD principal investigator
U of Calgary and Alberta Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViaValve™ Safety IV Catheter and ProtectIV® Plus Safety IV Catheter in people with Peripheral Intravenous Catheter, run by Smiths Medical, ASD, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical acceptability of PIVC insertion (time frame: Clinicians will provide the rating immediately after performing the insertion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.