Intravenous Injections Clinical Trial
Official title:
A Randomized Controlled Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population
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.
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:
1. Total number of attempts required for successful IV insertion.
2. 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
3. Incidence of blood extravasation resulting in a hematoma
4. Incidence of fluid extravasation delivered through catheter
5. Incidence of infection (phlebitis, dermatitis and induration) at insertion site through
72 hours or at the time of catheter removal, whichever occurs first.
6. Unplanned withdrawal of IV catheter
7. Overall complication rate composed from #3-6 above
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03220555 -
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|
N/A |