PhlebotomyNCT03109405
Assess Veinplicity Venous Access Device Safety and Effectiveness
A study testing Stimulation-assisted venous access and 20 guage cannula for IV, tourniquet optional in people with Phlebotomy, run by Physeon GmbH.
Trial summary
The purpose of this study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phlebotomy
- What is being tested?
- Stimulation-assisted venous access and 20 guage cannula for IV, tourniquet optional
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Aug 2015
- 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
- Subject ≥ 18 years of age
- Subject with history of failed venous access, venipuncture, or IV cannula placement
- Subject agreed to required follow-up
- Subject provided written, informed consent
Who cannot join
- Subject currently had compromised skin on either forearm or hand
- Subject currently on any blood thinning medication other than 81mg of aspirin
- Subject had been diagnosed with peripheral neuropathy, has had a complex fracture or surgery in the forearm, or has other condition that diminishes sensation in one or both arms, hands or fingers
- Subject had a demand type pacemaker or defibrillator
- Subject is female of child-bearing potential and had a positive urine pregnancy test
- Subject had a history of seizure, convulsions or epilepsy
- Subject had a known allergy to Epsom salts
- Subject had any other condition that may affect the ability to complete study requirements
About this study
Official title: A Prospective, Single Center, Randomized, Cross-over Clinical Trial to Assess the Safety and Effectiveness of the Veinplicity Venous Access Device
The purpose of this study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.
- Conditions
- Phlebotomy
- Being tested
- Stimulation-assisted venous access, 20 guage cannula for IV, tourniquet optional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation-assisted venous accessDevice
Also called Veinplicity Device
Stimulation-assisted venous access
20 guage cannula for IV, tourniquet optionalOther
Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation
| Study group | Role | What they receive |
|---|---|---|
| stimulation-assisted | Experimental | All subjects received treatment (stimulation-assisted) with the Veinplicity Device per the Instructions for Use. The subject underwent standard IV cannulation using a 20 gauge cannula into the available vein immediately after completion of device stimulation. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation. Receives: Device: Stimulation-assisted venous access; Other: 20 guage cannula for IV, tourniquet optional |
| standard IV cannulation | Other | The subject underwent standard IV cannulation using a 20 gauge cannula into the best available vein. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation. Receives: Other: 20 guage cannula for IV, tourniquet optional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful venous access on the first attempt.
Measured: 7 days
Rate of adverse events associated with either the treatment or the venous access site.
Measured: 7 days
Secondary outcomes (5)
User Perception of IV cannulation difficulty,
Measured: 7 days
Subject Preception of IV cannulation pain
Measured: 7 days
Subject Perception of Device stimulation
Measured: 7 days
Time required to achieve successful IV cannula placement
Measured: time from initial puncture to successful IV cannulation
Number of attempts required to achieve successful IV cannula placement
number of punctures from initial puncture to successful IV cannulation
Measured: over a 24 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhlebotomyStudies 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physeon GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leela Vrishabhendra, MD, Principal investigator, Medpace Medical Device
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109405
- Sponsor's protocol ID
- 292-13-280681
- Status last verified
- Apr 2018
- First submitted
- 21 Apr 2016
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Randomized, Cross-over Clinical Trial to Assess the Safety and Effectiveness of the Veinplicity Venous Access Device
- ClinicalTrials.gov ID
- NCT03109405
- Acronym / sponsor ID
- 292-13-280681
- Conditions
- Phlebotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Physeon GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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 study was to examine the Veinplicity Device as an adjunctive IV cannulation tool in subjects with a history of difficult to access veins. The Veinplicity Device is intended to improve venous access rates in compromised patients by taking advantage of the increased circulation that results from provoked muscle stimulation. The study collected information about the device, intravenous access, user and patient perceptions for IV access, and any device or procedural complications or other adverse events. Device use was examined with patients in both a prone and upright position.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation-assisted | Experimental | Device: Stimulation-assisted venous access, Other: 20 guage cannula for IV, tourniquet optionalAll subjects received treatment (stimulation-assisted) with the Veinplicity Device per the Instructions for Use. The subject underwent standard IV cannulation using a 20 gauge cannula into the available vein immediately after completion of device stimulation. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation. |
| standard IV cannulation | Other | Other: 20 guage cannula for IV, tourniquet optionalThe subject underwent standard IV cannulation using a 20 gauge cannula into the best available vein. Use of a tourniquet was at the discretion of the nurse performing the IV cannulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject ≥ 18 years of age
- Subject with history of failed venous access, venipuncture, or IV cannula placement
- Subject agreed to required follow-up
- Subject provided written, informed consent
Key exclusion criteria (8 listed)
- Subject currently had compromised skin on either forearm or hand
- Subject currently on any blood thinning medication other than 81mg of aspirin
- Subject had been diagnosed with peripheral neuropathy, has had a complex fracture or surgery in the forearm, or has other condition that diminishes sensation in one or both arms, hands or fingers
- Subject had a demand type pacemaker or defibrillator
- Subject is female of child-bearing potential and had a positive urine pregnancy test
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 |
|---|---|---|
| Stimulation-assisted venous accessAlso: Veinplicity DeviceStimulation-assisted venous access | Device | stimulation-assisted |
| 20 guage cannula for IV, tourniquet optionalStandard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation | Other | standard IV cannulation, stimulation-assisted |
Primary outcome
Rate of successful venous access on the first attempt.
Time frame: 7 days
Rate of adverse events associated with either the treatment or the venous access site.
Time frame: 7 days
5 secondary outcomes
User Perception of IV cannulation difficulty,
Time frame: 7 days
Subject Preception of IV cannulation pain
Time frame: 7 days
Subject Perception of Device stimulation
Time frame: 7 days
Time required to achieve successful IV cannula placement
Time frame: time from initial puncture to successful IV cannulation
Number of attempts required to achieve successful IV cannula placement
Time frame: over a 24 hour period
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 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Leela Vrishabhendra, MD principal investigator
Medpace Medical Device
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation-assisted venous access and 20 guage cannula for IV, tourniquet optional in people with Phlebotomy, run by Physeon GmbH.
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 4 inclusion and 8 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of successful venous access on the first attempt. (time frame: 7 days). The study lists 2 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 5 Apr 2018.