Back to resultsInjectable Bulking Agent Needle Guide (NG)
Primary Purpose
Urinary Incontinence, Intrinsic Sphincter Deficiency
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Needle Guided Periurethral Injection
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, ISD
Eligibility Criteria
Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.
Sites / Locations
- Mayo Clinic Jacksonville
- Advanced Urogynecology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injection with Needle Guide
Arm Description
Outcomes
Primary Outcome Measures
to evaluate the consistency of the location of the injection site and resulting location of bulking effect
Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide.
Secondary Outcome Measures
to evaluate the comparative ease of the injection procedure using the Bulking Agent Needle Guide as compared to the traditional transurethral or periurethral injection technique.
Full Information
NCT ID
NCT00763711
First Posted
September 29, 2008
Last Updated
January 9, 2012
Sponsor
Carbon Medical Technologies
1. Study Identification
Unique Protocol Identification Number
NCT00763711
Brief Title
Injectable Bulking Agent Needle Guide
Acronym
NG
Official Title
Injectable Bulking Agent Needle Guide
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carbon Medical Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Intrinsic Sphincter Deficiency
Keywords
Urinary Incontinence, ISD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection with Needle Guide
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Needle Guided Periurethral Injection
Intervention Description
Bulking Agent injection using a needle guide
Primary Outcome Measure Information:
Title
to evaluate the consistency of the location of the injection site and resulting location of bulking effect
Time Frame
at procedure
Title
Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
to evaluate the comparative ease of the injection procedure using the Bulking Agent Needle Guide as compared to the traditional transurethral or periurethral injection technique.
Time Frame
at procedure
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Klein
Organizational Affiliation
Carbon Medical Technologies
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Advanced Urogynecology
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
12. IPD Sharing Statement
Links:
URL
http://carbonmed.com
Description
Related Info
Learn more about this trial
Injectable Bulking Agent Needle Guide
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