Injections, IntravenousNCT03145519
A Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
A study testing Vasofix Certo Catheter and OptiVein Catheter in people with Injections, Intravenous and Administration, Intravenous, run by Optomeditech Oy at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Injections, Intravenous, Administration, Intravenous
- What is being tested?
- Vasofix Certo Catheter and OptiVein Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteEstonia
- Study dates
- 15 Feb 2017to 17 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
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.
Read the detailed description
The OptiVein IV Catheter is a sterile single use disposable intravascular cannulation device that is modified from CE certified Vasofix Certo Catheter from B.Braun with the additional features of an optical fiber and modified flashplug. The OptiVein System also includes an electronic unit.
The OptiVein Catheter shares a similar intended use and the same catheter components as the Vasofix Certo IV Catheter. Clinical data will be obtained to demonstrate that there is no change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter.
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.
Patients aged newborn to twelve (12) years requiring short-term use of an IV catheter to withdraw blood samples or to administer fluids or medications intravenously.
Participating sites will follow routine practice guidelines regarding the personnel responsible for inserting the catheters for this study, known herein as "operators." Operators must be professionally trained in IV catheter placement; educational background and level of experience of operator will be documented.
All Operators selected for participation in the study will undergo training on the protocol, Good Clinical Practice and the assembly and use of the OptiVein IV Catheter and Vasofix Certo IV catheter prior to enrolling patients into the study.
Randomization will be in a 1:1 fashion with assignment given by the electronic data capture (EDC) system.
- Being tested
- Vasofix Certo Catheter, OptiVein Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasofix Certo CatheterDevice
Placement of IV-catheter
OptiVein CatheterDevice
Placement of IV-catheter
| Study group | Role | What they receive |
|---|---|---|
| OptiVein | Experimental | Placement of IV-catheter and administration of treatment using OptiVein catheter. Receives: Device: OptiVein Catheter |
| Vasofix Certo | Active comparator | Placement of IV-catheter and administration of treatment using Vasofix Certo catheter. Receives: Device: Vasofix Certo Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate / During the procedure usually taking less than 1 minute
Secondary outcomes (7)
Number of attempts
Total number of attempts required for successful IV insertion.
Measured: Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes
Time to successful IV insertion
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
Measured: 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
Measured: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Incidence of fluid extravasation delivered through catheter
Measured: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Incidence of infection
Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
Measured: 72 hour follow-up or time of removal of catheter, whichever occurs first
Unplanned withdrawal of IV catheter
Measured: 72 hour follow-up or time of removal of catheter, whichever occurs first
Overall complication rate composed from #2-5 above
Measured: 72 hour follow-up or time of removal of catheter, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start15 Feb 2017
- Primary completion17 Sep 2017
- Study completion17 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injections, IntravenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optomeditech Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CardioMed Device Consultants, LLC
- Responsible party
- Sponsor
- Investigators
- Tuuli Metsvaht, MD, Principal investigator, Tartu University Hospital, Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145519
- Sponsor's protocol ID
- OMT-CT-004-PED
- Status last verified
- Sep 2018
- First submitted
- 20 Feb 2017
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
- ClinicalTrials.gov ID
- NCT03145519
- Acronym / sponsor ID
- OMT-CT-004-PED
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Optomeditech OyIndustry (pharma, biotech, devices)
- Collaborators
- CardioMed Device Consultants, LLC
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 17 Sep 2017 (actual)
- Study completion
- 17 Sep 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 IV Catheter is a sterile single use disposable intravascular cannulation device that is modified from CE certified Vasofix Certo Catheter from B.Braun with the additional features of an optical fiber and modified flashplug. The OptiVein System also includes an electronic unit.
The OptiVein Catheter shares a similar intended use and the same catheter components as the Vasofix Certo IV Catheter. Clinical data will be obtained to demonstrate that there is no change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter.
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.
Patients aged newborn to twelve (12) years requiring short-term use of an IV catheter to withdraw blood samples or to administer fluids or medications intravenously.
Participating sites will follow routine practice guidelines regarding the personnel responsible for inserting the catheters for this study, known herein as "operators." Operators must be professionally trained in IV catheter placement; educational background and level of experience of operator will be documented.
All Operators selected for participation in the study will undergo training on the protocol, Good Clinical Practice and the assembly and use of the OptiVein IV Catheter and Vasofix Certo IV catheter prior to enrolling patients into the study.
Randomization will be in a 1:1 fashion with assignment given by the electronic data capture (EDC) system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OptiVein | Experimental | Device: OptiVein CatheterPlacement of IV-catheter and administration of treatment using OptiVein catheter. |
| Vasofix Certo | Active comparator | Device: Vasofix Certo CatheterPlacement of IV-catheter and administration of treatment using Vasofix Certo catheter. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasofix Certo CatheterPlacement of IV-catheter | Device | Vasofix Certo |
| OptiVein CatheterPlacement of IV-catheter | Device | OptiVein |
Primary outcome
First attempt success rate
Time frame: Immediate / During the procedure usually taking less than 1 minute
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.
7 secondary outcomes
Number of attempts
Time frame: Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes
Time to successful IV insertion
Time frame: 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
Time frame: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Incidence of fluid extravasation delivered through catheter
Time frame: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Incidence of infection
Time frame: 72 hour follow-up or time of removal of catheter, whichever occurs first
Unplanned withdrawal of IV catheter
Time frame: 72 hour follow-up or time of removal of catheter, whichever occurs first
Overall complication rate composed from #2-5 above
Time frame: 72 hour follow-up or time of removal of catheter, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuuli Metsvaht, MD principal investigator
Tartu University Hospital, Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasofix Certo Catheter and OptiVein Catheter in people with Injections, Intravenous and Administration, Intravenous, run by Optomeditech Oy at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt success rate (time frame: Immediate / During the procedure usually taking less than 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.