A Randomized Controlled Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population

Intravenous Injections Clinical Trial

Official title:

A Randomized Controlled Open Label Trial to Assess the Safety and Efficacy of the OptiVein IV Catheter in an Oncologic Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02420028
• Other study ID #: OMT-CT-003-ONC
• Status: Terminated
• Phase: N/A
• Start date: April 2, 2015
• Est. completion date: August 5, 2016

Study information

• Verified date: September 2018
• Source: Optomeditech Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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:

1. Total number of attempts required for successful IV insertion.

2. 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

3. Incidence of blood extravasation resulting in a hematoma

4. Incidence of fluid extravasation delivered through catheter

5. Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.

6. Unplanned withdrawal of IV catheter

7. Overall complication rate composed from #3-6 above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 109
• Est. completion date: August 5, 2016
• Est. primary completion date: August 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients on an ongoing chemotherapy program thru peripheral veins delivery

2. Has difficult to access veins (class II or III) OR has experienced an unsuccessful IV start during his/her previous visit to the hospital

3. Requires peripheral IV therapy (catheter)

4. Has an insertion site in the forearm or hand free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos

5. Demonstrates cooperation with a catheter insertion and the study protocol

6. Patients 18 years of age or greater

Exclusion Criteria:

1. Patients receiving pre-warming of the insertion site

2. Is anesthetized

3. Has a life expectancy of less than one month

4. Transferred from the operating room less than 8 hours post-anasthesia

5. Any patient the research staff deem unobservable

6. The study IV site needs to be immobilized with a splint or other devices

7. Will require a power injection for a radiologic procedure during participation in this study

Related Conditions & MeSH terms

• Intravenous Injections

Intervention

Device:
• Insertion of OptiVein IV catheter
Placement of OptiVein IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
• Insertion of Vasofix Certo IV catheter
Placement of Vasofix Certo IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.

Locations

Country	Name	City	State
Finland	Docrates Cancer Center	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Optomeditech Oy	CardioMed Device Consultants, LLC

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful IV insertion on the first attempt	Successful placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.	Immediate
Secondary	Total number of attempts required for successful IV insertion		Immediate
Secondary	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	Immediate
Secondary	Incidence of blood extravasation resulting in a hematoma		Immediate
Secondary	Incidence of fluid extravasation delivered through catheter		Immediate
Secondary	Incidence of infection	phlebitis, dermatitis and induration at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.	After 72 hours or release from hospital, whichever occurs first.
Secondary	Unplanned withdrawal of IV catheter		Immediate