Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter (MCENPS)

Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter for Dialysis

The purpose of this study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement.

Study Overview

• Status: Completed
• Conditions: Pain; Dialysis Catheter
• Intervention / Treatment: Device: CentrosFLO Long Term Hemodialysis Catheter

Detailed Description

The CentrosFLO™ Tunneled Dialysis Catheter is a 15F dual-lumen, double-D shaped catheter similar to other "split tip" catheters in the market: outflow ("arterial") and return ("venous") lumens that separate, a subcutaneous Dacron® cuff, extension sets with clamps and caps, and construction from Carbothane® material. The CentrosFLO™ catheter contains two small pressure-relief holes near the tips.

The main difference of the CentrosFLO catheter is in the design of the tip. Current "split tip" catheters have two free ends that diverge, but are each essentially straight segments. In the CentrosFLO catheter the arterial lumen bends in an arc back towards the venous lumen, and the venous lumen bends towards the arterial lumen. As a result, the catheter has two curved surfaces that will rest against the vena cava wall to automatically "center" the catheter within the vein. The contact points of the catheter against the vena cava wall should be smaller and more disperse than with current straight-tip or split catheters. The following drawing demonstrates the design of the catheter, showing the current recommendation that the arterial port always be to the left.

The goal of the study is to demonstrate the stability of blood flow with the CentrosFLO catheter, during intermittent dialysis over a period of 6 months after placement. The investigators plan to enroll 10 patients in the study.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85217
      • Angiocare
  • California
    • Colton, California, United States, 92324
      • Arrowhead Regional Medical Center
    • Los Angeles, California, United States, 90134
      • Olive View- UCLA Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU School of Medicine
    • Lafayette, Indiana, United States, 47905
      • IU Health Arnett
  • Nevada
    • Reno, Nevada, United States, 89511
      • Sierra Nephrology
  • Ohio
    • Columbus, Ohio, United States, 43210
      • OSU Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who are initiating or continuing in-center intermittent hemodialysis who are scheduled to receive a tunneled dialysis catheter in the right or left internal jugular vein. The patients may have had a prior tunneled catheter for dialysis in the right IJ site.Patients will be expected to need use of the catheter for more than 45 days

Description

Inclusion Criteria:

• Adult patients who are initiating or continuing in-center intermittent hemodialysis who are scheduled to receive a tunneled dialysis catheter in the right or left internal jugular vein
• The patients may have had a prior tunneled catheter for dialysis in the right IJ site.
• Patients will be expected to need use of the catheter for more than 45 days

Exclusion Criteria:

• Patients in whom the catheter is planned to be placed into the same site as an existing catheter, by over-the-wire catheter exchange
• Patients unable to give informed consent

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CentrosFLO Long Term Hemodialysis Catheter; Schedule placement of catheter. Arterial tip of the catheter should be placed at or just above the junction of the right atrium and superior vena cava, with the arterial lumen on the left side of the catheter. The venous limb will extend into the right atrium. Catheter will be locked with the usual heparin lock solution for a newly placed catheter (at least 500 units per lumen). Fluoroscopic images will document tip position.

Device: CentrosFLO Long Term Hemodialysis Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint: Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months	Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint: Incidence of patency failure defined as blood flow rate below 300 mL/min or removal of catheter for failure of flow at any time during the study.	Incidence of patency failure defined as blood flow rate below 300 mL/min or removal of catheter for failure of flow at any time during the study.	1.5 years

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Investigators: Principal Investigator: Steven Ash, Consulting Physican

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 23, 2014
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Estimate): September 3, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 2013224