Injectable Bulking Agent Needle Guide
NCT00763711 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2012-01-10
Summary
The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.
Conditions
- Urinary Incontinence
- Intrinsic Sphincter Deficiency
Interventions
- DEVICE
-
Needle Guided Periurethral Injection
Bulking Agent injection using a needle guide
Sponsors & Collaborators
-
Carbon Medical Technologies
lead INDUSTRY
Principal Investigators
-
Dean Klein · Carbon Medical Technologies
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-06-30
- Primary Completion
- 2009-11-30
- Completion
- 2009-11-30
Countries
- United States
Study Locations
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