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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00836563
Other study ID # 0444-08-EP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2009
Est. completion date December 13, 2011

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement and the timing of these changes.


Description:

The purpose of this study is to determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement, and if they do, characterize the timing of these changes.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 13, 2011
Est. primary completion date December 13, 2011
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Age greater than or equal to 19 years 2. Planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days. 3. Cephalic and/or basilic vein diameter greater than or equal to 2.5 mm at the antecubital fossa to the axilla prior to AVG placement Exclusion Criteria: 1. Age less than 19 years 2. Hemodialysis access other than forearm loop graft surgery placement 3. Cephalic and/or basilic vein diameter less than 2.5 mm at any point from the antecubital fossa to the axilla 4. Prior hemodialysis access surgery in the arm receiving the forearm loop graft

Study Design


Locations

Country Name City State
United States University of Nebraska Medical Center/The Nebraska Medical Center Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Upper arm vein diameter 50% increase in upper arm vein diameter Six months
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