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

NCT02420028 | Terminated

• 1 other identifier: OMT-CT-003-ONC
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intravenous Injections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total number of attempts required for successful IV insertion

  Immediate

• Time to successful IV insertion

  Immediate

• Incidence of blood extravasation resulting in a hematoma

  Immediate

• Incidence of fluid extravasation delivered through catheter

  Immediate

• Incidence of infection

  After 72 hours or release from hospital, whichever occurs first.

Study Arms (2)

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.

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.

Device: Insertion of Vasofix Certo IV catheter

Interventions

Insertion of Vasofix Certo IV catheter DEVICE

Placement of Vasofix Certo IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.

Vasofix Certo IV catheter

Insertion of OptiVein IV catheter DEVICE

Placement of OptiVein IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.

OptiVein IV catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optomeditech Oy: lead
• CardioMed Device Consultants, LLC: collaborator

Study Sites (1)

Docrates Cancer Center

Helsinki, 00180, Finland

Location

Study Officials

• Tomi Wiklund, M.D, Ph.D.

  Docrates Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 17, 2015
• Study Start: April 2, 2015
• Primary Completion: August 5, 2016
• Study Completion: August 5, 2016
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

FI (1)