Peripheral Intravenous CathetersRIGHT IVNCT01792778
RIGHT IV Pilot Study
A study testing ViaValve Safety IV Catheter in people with Peripheral Intravenous Catheters, run by Smiths Medical, ASD, Inc. at 1 site in United States.
Trial summary
The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Intravenous Catheters
- What is being tested?
- ViaValve 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Willing and able to independently sign an English Informed Consent
- Have adequate veins for placement of IV catheters in both right and left upper extremities
Who cannot join
- Currently taking anti-coagulation medication
- Have a known bloodborne disease or bleeding tendency
- Have a known fear or adverse reaction to needles or blood
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Interprofessional Education and Resource Center
Minneapolis, Minnesota, 55455
About this study
Official title: Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study
The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.
- Conditions
- Peripheral Intravenous Catheters
- Being tested
- ViaValve Safety IV Catheter, Insyte Autoguard BC [Blood Control] Shielded IV Catheter
- Keywords
- IV Catheters, Blood control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViaValve Safety IV CatheterDevice
Insertion of the peripheral intravenous catheters into both upper extremities of subjects
Insyte Autoguard BC [Blood Control] Shielded IV CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| ViaValve Safety IV Catheter | Active comparator | Catheter insertion using the ViaValve Safety IV Catheter. Receives: Device: ViaValve Safety IV Catheter |
| Insyte Autoguard BC [Blood Control] Shielded IV Catheter | Active comparator | Catheter insertion using the Insyte Autoguard BC Shielded IV Catheter Receives: Device: Insyte Autoguard BC [Blood Control] Shielded IV Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance and acceptability
Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire.
Measured: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous CathetersStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smiths Medical, ASD, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori Schwartz, MBA, MSN, RN, PHN, Principal investigator, Smiths Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792778
- Sponsor's protocol ID
- RIGHT IV Pilot Study
- Acronym
- RIGHT IV
- Status last verified
- May 2014
- First submitted
- 8 Feb 2013
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study Comparing the Clinical Performance Two Blood Control Safety Peripheral Intravenous Catheters: A Pilot Study
- ClinicalTrials.gov ID
- NCT01792778
- Acronym / sponsor ID
- RIGHT IV / RIGHT IV Pilot Study
- Conditions
- Peripheral Intravenous Catheters
- Keywords
- IV Catheters, Blood control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Smiths Medical, ASD, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Feb 2013 (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 purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViaValve Safety IV Catheter | Active comparator | Device: ViaValve Safety IV CatheterCatheter insertion using the ViaValve Safety IV Catheter. |
| Insyte Autoguard BC [Blood Control] Shielded IV Catheter | Active comparator | Device: Insyte Autoguard BC [Blood Control] Shielded IV CatheterCatheter insertion using the Insyte Autoguard BC Shielded IV Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Willing and able to independently sign an English Informed Consent
- Have adequate veins for placement of IV catheters in both right and left upper extremities
Key exclusion criteria (4 listed)
- Currently taking anti-coagulation medication
- Have a known bloodborne disease or bleeding tendency
- Have a known fear or adverse reaction to needles or blood
- Women who are pregnant or nursing
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 CatheterInsertion of the peripheral intravenous catheters into both upper extremities of subjects | Device | ViaValve Safety IV Catheter |
| Insyte Autoguard BC [Blood Control] Shielded IV Catheter | Device | Insyte Autoguard BC [Blood Control] Shielded IV Catheter |
Primary outcome
Clinical performance and acceptability
Time frame: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.
Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire.
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 26 May 2016.
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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.
Lori Schwartz, MBA, MSN, RN, PHN principal investigator
Smiths Medical
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 in people with Peripheral Intravenous Catheters, run by Smiths Medical, ASD, Inc. at 1 site in United States.
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 3 inclusion and 4 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 26 May 2016. 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 United States. 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 performance and acceptability (time frame: IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected.). 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 26 May 2016.