Clinical trial NCT02349308: Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter
Official title: Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter for Dialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain; Dialysis Catheter
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1.5 years
Secondary outcomes:
measure: 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.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Angiocare
state: Arizona
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
city: Los Angeles
country: United States
facility: Olive View- UCLA Medical Center
state: California
city: Indianapolis
country: United States
facility: IU School of Medicine
state: Indiana
city: Lafayette
country: United States
facility: IU Health Arnett
state: Indiana
city: Reno
country: United States
facility: Sierra Nephrology
state: Nevada
city: Columbus
country: United States
facility: OSU Medical Center
state: Ohio
Study officials:
affiliation: Consulting Physican
name: Steven Ash
role: PRINCIPAL_INVESTIGATOR
References: