HeRO Vascular Access Device Bacteremia Study
NCT00889564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2017-08-08
Summary
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.
Conditions
- Hemodialysis
Interventions
- DEVICE
-
HeRO Vascular Access Device
Long-term subcutaneous vascular access device for hemodialysis
Sponsors & Collaborators
-
Integra Clinical Trial Solutions - statistical analysis
collaborator UNKNOWN -
Ross, John, M.D.
collaborator INDIV -
Merit Medical Systems, Inc.
lead INDUSTRY
Principal Investigators
-
John Ross, MD · Bamberg County Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-03-31
- Primary Completion
- 2007-03-31
- Completion
- 2007-03-31
Countries
- United States
Study Locations
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