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Dialysis Catheter Comparative Clinical Trial

This study is currently recruiting participants.
Verified by Tyco Healthcare Group, October 2008

Sponsored by: Tyco Healthcare Group
Information provided by: Tyco Healthcare Group
ClinicalTrials.gov Identifier: NCT00526123
  Purpose

The purpose of this clinical trial is to compare the longevity of two dialysis catheters.


Condition Intervention
End Stage Renal Disease
Device: Symmetric Tip Catheter
Device: Conventional Split-tip Catheter

MedlinePlus related topics:   Kidney Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Single Group Assignment
Official Title:   A Randomized, Open-Label Comparison of the Performance and Longevity of a Split-Tip Versus a Symmetric Tip Hemodialysis

Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:
  • Longevity of two types of dialysis catheters [ Time Frame: 35 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical intervention and catheter performance [ Time Frame: 35 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   596
Study Start Date:   September 2007
Estimated Study Completion Date:   May 2011
Estimated Primary Completion Date:   May 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
symmetric tip catheter
Device: Symmetric Tip Catheter
Dialysis catheter
2: Active Comparator
conventional split-tip catheter
Device: Conventional Split-tip Catheter
Dialysis Catheter

Detailed Description:

This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Subject must be 18 years of age or older.
  • Subject must meet labeled indication for hemodialysis.
  • Subject must have End Stage Renal Disease (ESRD).
  • Subject must have a patent right or left internal jugular vein.
  • Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks.
  • Subject must give written informed consent.

Exclusion Criteria:

  • Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study.
  • Subjects with active infection at the time of study enrollment.
  • Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia.
  • Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding.
  • Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period.
  • Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason.
  • Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study.
  • Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526123

Contacts
Contact: Theresa M Courtney, RN, BSN     508-261-8428    
Contact: Stephanie M Brucato     508-261-6567    

Locations
United States, Massachusetts
Tufts Medical Center     Recruiting
      Boston, Massachusetts, United States, 02111
      Contact: Stephanie M. Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Klemens Meyer, MD            
United States, New York
SUNY Stony Brook Medical Center     Recruiting
      Stony Brook, New York, United States, 11794
      Contact: Stephanie M Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Nand Wadhwa, MD            
United States, North Carolina
Eastern Nephrology Associates     Recruiting
      Greenville, North Carolina, United States, 27834
      Contact: Stephanie M. Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Mark Vannorsdall, MD            
Eastern Nephrology Associates     Recruiting
      New Bern, North Carolina, United States, 28562
      Contact: Stephanie M. Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Richard Blair, MD            
Dialysis Access Group of Wake Forest University, LLC     Recruiting
      Winston-Salem, North Carolina, United States, 27101
      Contact: Stephanie M. Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Tushar Vachharajani, MD            
Boice-Willis Clinic     Recruiting
      Rocky Mount, North Carolina, United States, 27804
      Contact: Stephanie M. Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Douglas Bunting, MD            
United States, Ohio
Toledo Hospital     Recruiting
      Toledo, Ohio, United States, 43606
      Contact: Stephanie M. Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Zakaria Assi, MD            
United States, Pennsylvania
Temple University Hospital     Recruiting
      Philadelphia, Pennsylvania, United States, 19140
      Contact: Stephanie M. Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Jean Lee, MD            
United States, Wisconsin
Medical College of Wisconsin     Recruiting
      Milwaukee, Wisconsin, United States, 53226
      Contact: Stephanie M Brucato     508-261-6567     stephanie.brucato@covidien.com    
      Principal Investigator: Hariprasad Trivedi, MD            

Sponsors and Collaborators
Tyco Healthcare Group

Investigators
Principal Investigator:     Klemens B Meyer, MD     Unaffiliated    
  More Information


Responsible Party:   Clinical Affairs ( Terri Courtney, Director Clinical Affairs )
Study ID Numbers:   341.26
First Received:   September 5, 2007
Last Updated:   October 3, 2008
ClinicalTrials.gov Identifier:   NCT00526123
Health Authority:   United States: Institutional Review Board

Keywords provided by Tyco Healthcare Group:
Dialysis  
Dialysis Catheter  
Kidney Disease  
Dialysis Clinic  
Chronic Catheter
Catheter
Kidney

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on October 16, 2008




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