Intravenous InjectionsNCT02420028
A Randomized Controlled Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population
A study testing Insertion of OptiVein IV catheter and Insertion of Vasofix Certo IV catheter in people with Intravenous Injections, run by Optomeditech Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Injections
- What is being tested?
- Insertion of OptiVein IV catheter and Insertion of Vasofix Certo IV catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteFinland
- Study dates
- 2 Apr 2015to 5 Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on an ongoing chemotherapy program thru peripheral veins delivery
- Has difficult to access veins (class II or III) OR has experienced an unsuccessful IV start during his/her previous visit to the hospital
- Requires peripheral IV therapy (catheter)
- Has an insertion site in the forearm or hand free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- Demonstrates cooperation with a catheter insertion and the study protocol
- Patients 18 years of age or greater
Who cannot join
- Patients receiving pre-warming of the insertion site
- Is anesthetized
- Has a life expectancy of less than one month
- Transferred from the operating room less than 8 hours post-anasthesia
- Any patient the research staff deem unobservable
- The study IV site needs to be immobilized with a splint or other devices
- Will 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
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.
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 study control and predicate device is the Vasofix Certo IV Catheter from B. Braun Medical Inc. This device is the base device for the OptiVein IV Catheter to which is added the optical fiber and 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 assess if there is a change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter.
Subject population consists of Oncologic patients who have either difficult to access veins or who have experienced an unsuccessful IV start during their previous visit to the hospital, requiring short-term use of an IV catheter to administer chemotherapy medications intravenously. Subjects may be enrolled multiple times, with each patient-visit being the unit of analysis.
Primary efficacy endpoint is 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.
167 and 167 patient-visits will be included in OptiVein or Vasofix Certo respectively (1:1 randomization), resulting in a total sample size of 334 visits. This sample size will provide 80% power to demonstrate the superiority of the OptiVein Catheter to the Vasifix Certo Catheter.
Secondary endpoints include:
- Total number of attempts required for 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
- Incidence of blood extravasation resulting in a hematoma
- Incidence of fluid extravasation delivered through catheter
- Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
- Unplanned withdrawal of IV catheter
- Overall complication rate composed from #3-6 above
- Conditions
- Intravenous Injections
- Being tested
- Insertion of OptiVein IV catheter, Insertion of Vasofix Certo IV catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of OptiVein IV catheterDevice
Placement of OptiVein IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
Insertion of Vasofix Certo IV catheterDevice
Placement of Vasofix Certo IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| OptiVein IV catheter | Experimental | Insertion of an IV catheter into the patient's vein, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. Receives: Device: Insertion of OptiVein IV catheter |
| Vasofix Certo IV catheter | Active comparator | Insertion of an IV catheter into the patient's vein, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. Receives: Device: Insertion of Vasofix Certo IV catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful IV insertion on the first attempt
Successful placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
Measured: Immediate
Secondary outcomes (6)
Total number of attempts required for successful IV insertion
Measured: 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
Measured: Immediate
Incidence of blood extravasation resulting in a hematoma
Measured: Immediate
Incidence of fluid extravasation delivered through catheter
Measured: Immediate
Incidence of infection
phlebitis, dermatitis and induration at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
Measured: After 72 hours or release from hospital, whichever occurs first.
Unplanned withdrawal of IV catheter
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study start2 Apr 2015
- Primary completion5 Aug 2016
- Study completion5 Aug 2016
Why it stopped: Inability to recruit patients sufficiently
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous InjectionsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optomeditech Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CardioMed Device Consultants, LLC
- Responsible party
- Sponsor
- Investigators
- Tomi Wiklund, M.D, Ph.D., Principal investigator, Docrates Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420028
- Sponsor's protocol ID
- OMT-CT-003-ONC
- Status last verified
- Sep 2018
- First submitted
- 9 Apr 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- 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 Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population
- ClinicalTrials.gov ID
- NCT02420028
- Acronym / sponsor ID
- OMT-CT-003-ONC
- Conditions
- Intravenous Injections
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit patients sufficiently
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Optomeditech OyIndustry (pharma, biotech, devices)
- Collaborators
- CardioMed Device Consultants, LLC
- Study start
- 2 Apr 2015
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 17 Apr 2015 (estimated)
- 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 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.
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 study control and predicate device is the Vasofix Certo IV Catheter from B. Braun Medical Inc. This device is the base device for the OptiVein IV Catheter to which is added the optical fiber and 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 assess if there is a change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter.
Subject population consists of Oncologic patients who have either difficult to access veins or who have experienced an unsuccessful IV start during their previous visit to the hospital, requiring short-term use of an IV catheter to administer chemotherapy medications intravenously. Subjects may be enrolled multiple times, with each patient-visit being the unit of analysis.
Primary efficacy endpoint is 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.
167 and 167 patient-visits will be included in OptiVein or Vasofix Certo respectively (1:1 randomization), resulting in a total sample size of 334 visits. This sample size will provide 80% power to demonstrate the superiority of the OptiVein Catheter to the Vasifix Certo Catheter.
Secondary endpoints include:
- Total number of attempts required for 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
- Incidence of blood extravasation resulting in a hematoma
- Incidence of fluid extravasation delivered through catheter
- Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
- Unplanned withdrawal of IV catheter
- Overall complication rate composed from #3-6 above
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OptiVein IV catheter | Experimental | Device: Insertion of OptiVein IV catheterInsertion of an IV catheter into the patient's vein, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. |
| Vasofix Certo IV catheter | Active comparator | Device: Insertion of Vasofix Certo IV catheterInsertion of an IV catheter into the patient's vein, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients on an ongoing chemotherapy program thru peripheral veins delivery
- Has difficult to access veins (class II or III) OR has experienced an unsuccessful IV start during his/her previous visit to the hospital
- Requires peripheral IV therapy (catheter)
- Has an insertion site in the forearm or hand free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
- Demonstrates cooperation with a catheter insertion and the study protocol
Key exclusion criteria (7 listed)
- Patients receiving pre-warming of the insertion site
- Is anesthetized
- Has a life expectancy of less than one month
- Transferred from the operating room less than 8 hours post-anasthesia
- Any patient the research staff deem unobservable
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 |
|---|---|---|
| Insertion of OptiVein IV catheterPlacement of OptiVein IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. | Device | OptiVein IV catheter |
| Insertion of Vasofix Certo IV catheterPlacement of Vasofix Certo IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal. | Device | Vasofix Certo IV catheter |
Primary outcome
Successful IV insertion on the first attempt
Time frame: Immediate
Successful placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
6 secondary outcomes
Total number of attempts required for successful IV insertion
Time frame: Immediate
Time to successful IV insertion
Time frame: Immediate
Incidence of blood extravasation resulting in a hematoma
Time frame: Immediate
Incidence of fluid extravasation delivered through catheter
Time frame: Immediate
Incidence of infection
Time frame: After 72 hours or release from hospital, whichever occurs first.
Unplanned withdrawal of IV catheter
Time frame: Immediate
Results and safety
The study was stopped early (reason given: Inability to recruit patients sufficiently). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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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.
Tomi Wiklund, M.D, Ph.D. principal investigator
Docrates Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of OptiVein IV catheter and Insertion of Vasofix Certo IV catheter in people with Intravenous Injections, run by Optomeditech Oy at 1 site in Finland.
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 7 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: stopped early, 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 Finland. 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 was stopped early (reason given: Inability to recruit patients sufficiently). Results are not available in the source record.
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?
Successful IV insertion on the first attempt (time frame: Immediate). 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.