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

NCT ID: NCT03145519

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2017-09-17

Brief 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

Study Design

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

Study Groups

OptiVein

Placement of IV-catheter and administration of treatment using OptiVein catheter.

Group Type: EXPERIMENTAL

OptiVein Catheter

Intervention Type: DEVICE

Placement of IV-catheter

Vasofix Certo

Placement of IV-catheter and administration of treatment using Vasofix Certo catheter.

Group Type: ACTIVE_COMPARATOR

Vasofix Certo Catheter

Intervention Type: DEVICE

Placement of IV-catheter

Interventions

Vasofix Certo Catheter

Placement of IV-catheter

Intervention Type: DEVICE

OptiVein Catheter

Placement of IV-catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged newborn to 12 years
• Has written or verbal order for insertion of an IV
• Requires peripheral IV therapy (catheter)
• Has an insertion site in the forearm, hand, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
• Demonstrates cooperation with a catheter insertion and the study protocol
• Informed consent has been obtained

Exclusion Criteria

• Life expectancy less than 72h.
• Any child the research staff deem unobservable
• The study IV catheter site will be placed below an old infusion site
• Will likely require a power injection for a radiologic procedure during participation in this study

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioMed Device Consultants, LLC

INDUSTRY

Sponsor Role: collaborator

Optomeditech Oy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tuuli Metsvaht, MD

Role: PRINCIPAL_INVESTIGATOR

Tartu University Hospital, Children's Clinic

Locations

Tartu University Hospital, Children's Clinic

Tartu, , Estonia

Countries

Estonia

Other Identifiers

OMT-CT-004-PED

Identifier Type: -

Identifier Source: org_study_id