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

NCT03145519 | Completed

• 1 other identifier: OMT-CT-004-PED
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Injections, Intravenous; Administration, Intravenous

Outcome Measures

Primary Outcomes (1)

• First attempt success rate

  Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.

  Immediate / During the procedure usually taking less than 1 minute

Secondary Outcomes (7)

• Number of attempts

  Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes

• Time to successful IV insertion

  Immediate / During the procedure usually taking less than 1 minute if successful with first stick or within 30 minutes if further attempts are required

• Incidence of blood extravasation resulting in a hematoma

  Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first

• Incidence of fluid extravasation delivered through catheter

  Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first

• Incidence of infection

  72 hour follow-up or time of removal of catheter, whichever occurs first

Study Arms (2)

OptiVein

EXPERIMENTAL

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

Device: OptiVein Catheter

Vasofix Certo

ACTIVE COMPARATOR

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

Device: Vasofix Certo Catheter

Interventions

Vasofix Certo Catheter DEVICE

Placement of IV-catheter

Vasofix Certo

OptiVein Catheter DEVICE

Placement of IV-catheter

OptiVein

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optomeditech Oy: lead
• CardioMed Device Consultants, LLC: collaborator

Study Sites (1)

Tartu University Hospital, Children's Clinic

Tartu, 51014, Estonia

Location

Study Officials

• Tuuli Metsvaht, MD

  Tartu University Hospital, Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: May 9, 2017
• Study Start: February 15, 2017
• Primary Completion: September 17, 2017
• Study Completion: September 17, 2017
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)