Difficult-to-access Veins for Intravenous CannulationPhase 3NCT03752632
Veinplicity for Improved Venous Access: The VIVA Trial
A Phase 3 study testing Veinplicity with tourniquet and Tourniquet in people with Difficult-to-access Veins for Intravenous Cannulation, run by Physeon GmbH at 3 sites in United States.
Trial summary
This study will assess the safety and effectiveness of the Veinplicity device to improve the visualization and palpability of difficult-to-access veins for intravenous cannulation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Difficult-to-access Veins for Intravenous Cannulation
- What is being tested?
- Veinplicity with tourniquet and Tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2018to 22 Jul 2019
- Phase
- Phase 3
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 22 years old.
- Subject is assessed as having fair or poor vein quality.
- Subject's both arms are suitable for cannulation.
- Subject will not suffer harm from a delay in having an IV established as determined by the treating clinician.
Who cannot join
- Subject has existing intravenous access.
- Subject has a planned or existing intra-arterial access.
- Subject has broken, infected or irritated skin and/or dermatological conditions, e.g., eczema, psoriasis and/or allergic reactions, on either forearm.
- Subject has an active implantable medical device.
- Subject wears a transdermal drug delivery patch on her/his forearm.
- Subject has an active/suspected deep vein thrombosis or thrombophlebitis, impaired circulation, impaired sensation, active/uncontrolled bleeding, recently radiated tissue, recent fracture, recent injury or surgery resulting in blood loss > 100 mL, osteoporosis, localized abscess, localized tuberculosis, and/or a chronic wound with potential underlying osteomyelitis.
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- Subject has impaired cognition or communication (unable to provide accurate feedback).
- Subject has a history of seizures and/or epilepsy, and/or a recent seizure, possible recent seizure or a history of possible seizures.
- Subject is pregnant and/or breastfeeding at the time of study enrollment.
- Subject has, at the site of or in between Veinplicity electrode application sites, an active/suspected malignancy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Midwest Immunology Clinic and Infusion Center
Plymouth, Minnesota, 55446
Mayo Clinic-Rochester
Rochester, Minnesota, 55905
Regions Hospital
Saint Paul, Minnesota, 55101
About this study
This study will assess the safety and effectiveness of the Veinplicity device to improve the visualization and palpability of difficult-to-access veins for intravenous cannulation.
Read the detailed description
This is a prospective, randomized controlled study that will assess ability of Veinplicity to improve successful peripheral vein cannulation at the first stick in enrolled subjects. Potential subjects will undergo a peripheral vein assessment by a study clinician, which is standard of care prior to peripheral vein cannulation (PVC) for the establishment of intravenous (IV) access. Adults who are assessed as having "fair or poor" vein quality will be consented, enrolled and randomized into the study. Subjects will be randomized in a 1:1 ratio to either (1) tourniquet alone (control group); or (2) Veinplicity with tourniquet (treatment group). The primary endpoint is first-stick success. Clinicians will use an 18-, 20- or 22-gauge cannula. Clinician and subject satisfaction will be separately assessed using surveys on Day 0. Subjects in both groups will be followed for one day (either phone or in-hospital visit) after enrollment for safety. Qualified study clinicians must have at least one year of experience inserting peripheral IVs and must perform an average of five PVCs per week. The primary hypothesis to be tested is: Veinplicity with tourniquet is superior to tourniquet alone for successful peripheral vein access at first stick when used to cannulate subjects assessed as having a fair or poor level of vein quality. It is expected that this study will enroll approximately 246 subjects; 123 per study group. It is expected that up to five sites will be involved in this study. A planned interim analysis will be conducted to reassess the study planned sample size when approximately 50% of subjects have been enrolled. Enrollment will not stop during the interim analysis activities. Safety will be evaluated by the collection and analysis of the incidence and severity of all procedure- and/or device-related adverse events through the Day 1 phone call/visit.
- Being tested
- Veinplicity with tourniquet, Tourniquet
- Keywords
- intravenous, peripheral vein, cannulation, IV access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veinplicity with tourniquetDevice
Veinplicity will be used with a tourniquet
TourniquetDevice
A tourniquet alone will be used.
| Study group | Role | What they receive |
|---|---|---|
| Veinplicity with tourniquet (treatment) | Experimental | Veinplicity with tourniquet Receives: Device: Veinplicity with tourniquet |
| Tourniquet (control) | Active comparator | Control: Tourniquet Receives: Device: Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-stick success when accessing a peripheral vein for cannulation
successful peripheral vein access for the first-stick with use of Veinplicity with tourniquet versus tourniquet alone
Measured: Day 0
Device and/or procedure-related adverse events
Safety will be evaluated by the collection and analysis of the incidence and severity of all procedure- and/or device-related adverse events through the Day 1 post-insertion phone call/visit.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start1 Nov 2018
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Why it stopped: Business reasons not related to safety or trial conduct
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult-to-access Veins for Intravenous CannulationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physeon GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Responsible party
- Sponsor
- Investigators
- Gregory J Schears, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752632
- Sponsor's protocol ID
- PHY0011
- Status last verified
- Oct 2019
- First submitted
- 13 Nov 2018
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veinplicity for Improved Venous Access: The VIVA Trial
- ClinicalTrials.gov ID
- NCT03752632
- Acronym / sponsor ID
- PHY0011
- Keywords
- intravenous, peripheral vein, cannulation, IV access
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons not related to safety or trial conduct
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Physeon GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Regulatory and Clinical Research Institute Inc
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 26 Nov 2018 (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.
This study will assess the safety and effectiveness of the Veinplicity device to improve the visualization and palpability of difficult-to-access veins for intravenous cannulation.
Detailed description
This is a prospective, randomized controlled study that will assess ability of Veinplicity to improve successful peripheral vein cannulation at the first stick in enrolled subjects. Potential subjects will undergo a peripheral vein assessment by a study clinician, which is standard of care prior to peripheral vein cannulation (PVC) for the establishment of intravenous (IV) access. Adults who are assessed as having "fair or poor" vein quality will be consented, enrolled and randomized into the study. Subjects will be randomized in a 1:1 ratio to either (1) tourniquet alone (control group); or (2) Veinplicity with tourniquet (treatment group). The primary endpoint is first-stick success. Clinicians will use an 18-, 20- or 22-gauge cannula. Clinician and subject satisfaction will be separately assessed using surveys on Day 0. Subjects in both groups will be followed for one day (either phone or in-hospital visit) after enrollment for safety. Qualified study clinicians must have at least one year of experience inserting peripheral IVs and must perform an average of five PVCs per week. The primary hypothesis to be tested is: Veinplicity with tourniquet is superior to tourniquet alone for successful peripheral vein access at first stick when used to cannulate subjects assessed as having a fair or poor level of vein quality. It is expected that this study will enroll approximately 246 subjects; 123 per study group. It is expected that up to five sites will be involved in this study. A planned interim analysis will be conducted to reassess the study planned sample size when approximately 50% of subjects have been enrolled. Enrollment will not stop during the interim analysis activities. Safety will be evaluated by the collection and analysis of the incidence and severity of all procedure- and/or device-related adverse events through the Day 1 phone call/visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veinplicity with tourniquet (treatment) | Experimental | Device: Veinplicity with tourniquetVeinplicity with tourniquet |
| Tourniquet (control) | Active comparator | Device: TourniquetControl: Tourniquet |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is ≥ 22 years old.
- Subject is assessed as having fair or poor vein quality.
- Subject's both arms are suitable for cannulation.
- Subject will not suffer harm from a delay in having an IV established as determined by the treating clinician.
Key exclusion criteria (10 listed)
- Subject has existing intravenous access.
- Subject has a planned or existing intra-arterial access.
- Subject has broken, infected or irritated skin and/or dermatological conditions, e.g., eczema, psoriasis and/or allergic reactions, on either forearm.
- Subject has an active implantable medical device.
- Subject wears a transdermal drug delivery patch on her/his forearm.
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 |
|---|---|---|
| Veinplicity with tourniquetVeinplicity will be used with a tourniquet | Device | Veinplicity with tourniquet (treatment) |
| TourniquetA tourniquet alone will be used. | Device | Tourniquet (control) |
Primary outcome
First-stick success when accessing a peripheral vein for cannulation
Time frame: Day 0
successful peripheral vein access for the first-stick with use of Veinplicity with tourniquet versus tourniquet alone
Device and/or procedure-related adverse events
Time frame: Day 1
Safety will be evaluated by the collection and analysis of the incidence and severity of all procedure- and/or device-related adverse events through the Day 1 post-insertion phone call/visit.
Results and safety
The study was stopped early (reason given: Business reasons not related to safety or trial conduct). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
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.
Gregory J Schears, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Veinplicity with tourniquet and Tourniquet in people with Difficult-to-access Veins for Intravenous Cannulation, run by Physeon GmbH at 3 sites 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons not related to safety or trial conduct). Results are not available in the source record.
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?
First-stick success when accessing a peripheral vein for cannulation (time frame: Day 0). 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 30 Oct 2019.