Status:
TERMINATED
A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
Lead Sponsor:
Optomeditech Oy
Collaborating Sponsors:
Hospital District of Helsinki and Uusimaa
CardioMed Device Consultants, LLC
Conditions:
Peripheral Venous Catheterization
Eligibility:
All Genders
Up to 12 years
Phase:
NA
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 OptiV...
Detailed Description
The OptiVein System uses transillumination of skin tissue to aid in cannulation and consists of the OptiVein IV Catheter with an integrated optical fiber, and an electronic unit. The electronic unit i...
Eligibility Criteria
Inclusion
- 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 hand, forearm, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- Demonstrates cooperation with a catheter insertion and the study protocol
Exclusion
- In the newborn nursery or intensive care units (neonatal or pediatric)
- On patient-controlled analgesia pump
- Patient is anesthetized
- Terminally ill
- Transferred from the operating room less than 8 hours postanasthesia
- Any child the research staff deem unobservable
- The study IV catheter site will be placed below an old infusion site
- The study IV site needs to be immobilized with a splint or other devices
- Has or has had a previous IV catheter related phlebitis or infiltration during current hospitalization
- Will require a power injection for a radiologic procedure during participation in this study
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 25 2016
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT02265380
Start Date
October 1 2014
End Date
August 25 2016
Last Update
March 1 2017
Active Locations (1)
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1
Helsinki and Uusimaa Hospital District, Children's Hospital
Helsinki, Finland, 00029