NCT03145519

A Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Optomeditech Oy · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric 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 OptiVein Catheter shares a similar intended use and the same catheter components as the Vasofix Certo IV Catheter. Clinical data will be obtained to demonstrate that there is no change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter. A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt. Patients aged newborn to twelve (12) years requiring short-term use of an IV catheter to withdraw blood samples or to administer fluids or medications intravenously. Participating sites will follow routine practice guidelines regarding the personnel responsible for inserting the catheters for this study, known herein as "operators." Operators must be professionally trained in IV catheter placement; educational background and level of experience of operator will be documented. All Operators selected for participation in the study will undergo training on the protocol, Good Clinical Practice and the assembly and use of the OptiVein IV Catheter and Vasofix Certo IV catheter prior to enrolling patients into the study. Randomization will be in a 1:1 fashion with assignment given by the electronic data capture (EDC) system.

Conditions

• Injections, Intravenous
• Administration, Intravenous

Interventions

Type	Name	Description
DEVICE	Vasofix Certo Catheter	Placement of IV-catheter
DEVICE	OptiVein Catheter	Placement of IV-catheter

Timeline

• Start date: 2017-02-15
• Primary completion: 2017-09-17
• Completion: 2017-09-17
• First posted: 2017-05-09
• Last updated: 2018-09-13

Locations

1 site across 1 country: Estonia