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

NCT02265380 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2017-03-01

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

  • Peripheral Venous Catheterization

Interventions

DEVICE

Placement of IV catheter

Sponsors & Collaborators

  • Hospital District of Helsinki and Uusimaa

    collaborator OTHER

  • CardioMed Device Consultants, LLC

    collaborator INDUSTRY

  • Optomeditech Oy

    lead INDUSTRY

Principal Investigators

  • Tomi Taivainen, MD, PhD · Hospital District of Helsinki and Uusimaa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-08-25
Completion
2016-08-25

Countries

  • Finland

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 NCT02265380 on ClinicalTrials.gov