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

NCT03145519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2018-09-13

No results posted yet for this study

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.

Conditions

  • Injections, Intravenous
  • Administration, Intravenous

Interventions

DEVICE

Vasofix Certo Catheter

Placement of IV-catheter

DEVICE

OptiVein Catheter

Placement of IV-catheter

Sponsors & Collaborators

  • CardioMed Device Consultants, LLC

    collaborator INDUSTRY

  • Optomeditech Oy

    lead INDUSTRY

Principal Investigators

  • Tuuli Metsvaht, MD · Tartu University Hospital, Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2017-09-17
Completion
2017-09-17

Countries

  • Estonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03145519 on ClinicalTrials.gov