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A Randomized Controlled Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population

NCT02420028 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2018-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Intravenous Injections

Interventions

DEVICE

Insertion of OptiVein IV catheter

Placement of OptiVein IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.

DEVICE

Insertion of Vasofix Certo IV catheter

Placement of Vasofix Certo IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.

Sponsors & Collaborators

  • CardioMed Device Consultants, LLC

    collaborator INDUSTRY

  • Optomeditech Oy

    lead INDUSTRY

Principal Investigators

  • Tomi Wiklund, M.D, Ph.D. · Docrates Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-02
Primary Completion
2016-08-05
Completion
2016-08-05

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 NCT02420028 on ClinicalTrials.gov