Pain; Dialysis CatheterMCENPSNCT02349308
Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter
An observational study of Pain; Dialysis Catheter, run by Merit Medical Systems, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain; Dialysis Catheter
- What is being tested?
- CentrosFLO Long Term Hemodialysis Catheter
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2013to Jul 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Arrowhead Regional Medical Center
Colton, California, 92324
OSU Medical Center
Columbus, Ohio, 43210
IU School of Medicine
Indianapolis, Indiana, 46202
IU Health Arnett
Lafayette, Indiana, 47905
Olive View- UCLA Medical Center
Los Angeles, California, 90134
Sierra Nephrology
Reno, Nevada, 89511
Angiocare
Tucson, Arizona, 85217
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain; Dialysis Catheter
- Being tested
- CentrosFLO Long Term Hemodialysis Catheter
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentrosFLO Long Term Hemodialysis CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CentrosFLO Long Term Hemodialysis Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1.5 years
Secondary outcomes (1)
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain; Dialysis CatheterStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Ash, Principal investigator, Consulting Physican
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349308
- Sponsor's protocol ID
- 2013224
- Acronym
- MCENPS
- Status last verified
- Jan 2015
- First submitted
- 23 Sep 2014
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance of the CentrosFLO™ Tunneled IJ Catheter for Dialysis
- ClinicalTrials.gov ID
- NCT02349308
- Acronym / sponsor ID
- MCENPS / 2013224
- Conditions
- Pain; Dialysis Catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Jan 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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CentrosFLO Long Term Hemodialysis Catheter | – | Device: CentrosFLO Long Term Hemodialysis CatheterSchedule 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| CentrosFLO Long Term Hemodialysis Catheter | Device | CentrosFLO Long Term Hemodialysis Catheter |
Primary outcome
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
Time frame: 1.5 years
Stability of hydraulic resistance measured as normalized arterial pressure in mmHg/mL/min by dialysis flow meter weekly for up to six months
1 secondary outcome
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.
Time frame: 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2015.
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.
Steven Ash principal investigator
Consulting Physican
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain; Dialysis Catheter, run by Merit Medical Systems, Inc. at 7 sites in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: 1.5 years). 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 3 Sep 2015.