Femoral Micropuncture or Routine Introducer Study
NCT01103141 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143
Last updated 2017-05-11
Summary
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels.
Conditions
- Complications
Interventions
- DEVICE
-
Micropuncture needle set
Groin access for vascular intervention
- DEVICE
-
Standard gauge-18 needle set
Groin access for vascular intervention
Sponsors & Collaborators
-
Cook Group Incorporated
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- United States
Study Locations
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