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Sponsored by: |
Tyco Healthcare Group |
Information provided by: | Tyco Healthcare Group |
ClinicalTrials.gov Identifier: | NCT00526123 |
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 |
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 |
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
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Device: Symmetric Tip Catheter
Dialysis catheter
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2: Active Comparator
conventional split-tip catheter
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Device: Conventional Split-tip Catheter
Dialysis Catheter
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Theresa M Courtney, RN, BSN | 508-261-8428 | |
Contact: Stephanie M Brucato | 508-261-6567 |
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 |
Tyco Healthcare Group |
Principal Investigator: | Klemens B Meyer, MD | Unaffiliated |
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 |
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