Veinplicity for Improved Venous Access: The VIVA Trial

NCT ID: NCT03752632

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-07-22

Brief 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.

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.

Conditions

Difficult-to-access Veins for Intravenous Cannulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Veinplicity with tourniquet (treatment)

Veinplicity with tourniquet

Group Type: EXPERIMENTAL

Veinplicity with tourniquet

Intervention Type: DEVICE

Veinplicity will be used with a tourniquet

Tourniquet (control)

Control: Tourniquet

Group Type: ACTIVE_COMPARATOR

Tourniquet

Intervention Type: DEVICE

A tourniquet alone will be used.

Interventions

Veinplicity with tourniquet

Veinplicity will be used with a tourniquet

Intervention Type: DEVICE

Tourniquet

A tourniquet alone will be used.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regulatory and Clinical Research Institute Inc

OTHER

Sponsor Role: collaborator

Physeon GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory J Schears, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Midwest Immunology Clinic and Infusion Center

Plymouth, Minnesota, United States

Mayo Clinic-Rochester

Rochester, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

PHY0011

Identifier Type: -

Identifier Source: org_study_id