A Randomized Controlled Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population

Study Overview
=================
Brief Summary
-----------------
A prospective, single-center, open-label, randomized controlled trial to assess the safety and efficacy of the OptiVein IV Catheter in an oncology population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.

Detailed Description
-----------------
The OptiVein IV Catheter is a sterile single use disposable intravascular cannulation device that is modified from CE certified Vasofix Certo Catheter from B.Braun with the additional features of an optical fiber and modified flashplug. The OptiVein System also includes an electronic unit. The study control and predicate device is the Vasofix Certo IV Catheter from B. Braun Medical Inc. This device is the base device for the OptiVein IV Catheter to which is added the optical fiber and electronic unit. The OptiVein Catheter shares a similar intended use and the same catheter components as the Vasofix Certo IV Catheter. Clinical data will be obtained to assess if there is a change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter. Subject population consists of Oncologic patients who have either difficult to access veins or who have experienced an unsuccessful IV start during their previous visit to the hospital, requiring short-term use of an IV catheter to administer chemotherapy medications intravenously. Subjects may be enrolled multiple times, with each patient-visit being the unit of analysis. Primary efficacy endpoint is successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. 167 and 167 patient-visits will be included in OptiVein or Vasofix Certo respectively (1:1 randomization), resulting in a total sample size of 334 visits. This sample size will provide 80% power to demonstrate the superiority of the OptiVein Catheter to the Vasifix Certo Catheter. Secondary endpoints include: Total number of attempts required for successful IV insertion. Time to successful IV insertion, defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal Incidence of blood extravasation resulting in a hematoma Incidence of fluid extravasation delivered through catheter Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first. Unplanned withdrawal of IV catheter Overall complication rate composed from #3-6 above

Official Title
-----------------
A Randomized Controlled Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population

Conditions
-----------------
Intravenous Injections

Intervention / Treatment
-----------------
* Device: Insertion of OptiVein IV catheter
* Device: Insertion of Vasofix Certo IV catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on an ongoing chemotherapy program thru peripheral veins delivery Has difficult to access veins (class II or III) OR has experienced an unsuccessful IV start during his/her previous visit to the hospital Requires peripheral IV therapy (catheter) Has an insertion site in the forearm or hand free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos Demonstrates cooperation with a catheter insertion and the study protocol Patients 18 years of age or greater Exclusion Criteria: Patients receiving pre-warming of the insertion site Is anesthetized Has a life expectancy of less than one month Transferred from the operating room less than 8 hours post-anasthesia Any patient the research staff deem unobservable The study IV site needs to be immobilized with a splint or other devices Will require a power injection for a radiologic procedure during participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OptiVein IV catheter<br>Insertion of an IV catheter into the patient's vein, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. | Device: Insertion of OptiVein IV catheter<br>* Placement of OptiVein IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.<br>|
| Active Comparator: Vasofix Certo IV catheter<br>Insertion of an IV catheter into the patient's vein, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. | Device: Insertion of Vasofix Certo IV catheter<br>* Placement of Vasofix Certo IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful IV insertion on the first attempt | Successful placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of attempts required for successful IV insertion |  | Immediate | 
| Time to successful IV insertion | Defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal | Immediate | 
| Incidence of blood extravasation resulting in a hematoma |  | Immediate | 
| Incidence of fluid extravasation delivered through catheter |  | Immediate | 
| Incidence of infection | phlebitis, dermatitis and induration at insertion site through 72 hours or at the time of catheter removal, whichever occurs first. | After 72 hours or release from hospital, whichever occurs first. | 
| Unplanned withdrawal of IV catheter |  | Immediate |