A Randomized Controlled Trial to Demonstrate the Safety a... | NCT02265380

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

NCT02265380

Sponsor

Optomeditech Oy

Status

Terminated

Last Update Posted

Mar 1, 2017Actual

Enrollment

188Estimated

Phase

Not Applicable

Conditions

Peripheral Venous Catheterization

Interventions

Placement of IV catheter

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inability to recruit patients sufficiently

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Aug 25, 2016Actual

Completion Date

Aug 25, 2016Actual

First Submitted Date

Oct 9, 2014

First Submission Date that Met QC Criteria

Oct 14, 2014

First Posted Date

Oct 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Name	Class
Hospital District of Helsinki and Uusimaa	OTHER
CardioMed Device Consultants, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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 is a portable internally powered generator of low power visible laser light of green color. The electronic unit generates visible light, which is released from the tip of the needle into the soft tissue around the tip of the IV catheter. Light is visible through the skin and helps mark the location of the tip of the needle under the skin and against the vein.

In addition to pinpointing the exact location of the tip of the needle, the OptiVein System informs the user of the exact moment of penetration of the tip of the needle into the blood vessel. Hemoglobin in blood strongly absorbs visible light of specific wavelengths, so when the needle enters the blood vessel, the light is instantly absorbed by blood, which causes instant fading of skin transillumination. Instant disappearance of tissue illumination indicates successful venipuncture. The user can then lower the angle of the needle and start to advance the cannula over the needle into the blood vessel. Such optical confirmation is much faster than the traditional observation of blood in the flashback chamber of the needle and should lead to increased first-attempt success rates and decreased cannulation-related complications.

The use of OptiVein device will be compared to the use of a traditional IV catheter to explore the potential increase of effectiveness of cannulation with OptiVein versus traditional IV catheters.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment with OptiVein	Experimental	The patient will have an IV catheter placed with the use of OptiVein device.	Device: Placement of IV catheter
Treatment with Vasofix Certo	Active Comparator	The patient will have an IV catheter placed with the use of Vasofix Certo device.	Device: Placement of IV catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placement of IV catheter	Device		Treatment with OptiVein Treatment with Vasofix Certo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful IV insertion on the first attempt	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

Secondary Outcomes

Measure	Description	Time Frame
Total number of attempts required for successful IV insertion		Immediate
Time to successful IV insertion	Defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tomi Taivainen, MD, PhD	Hospital District of Helsinki and Uusimaa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki and Uusimaa Hospital District, Children's Hospital		Helsinki		00029	Finland