Injectable Bulking Agent Needle Guide

Urinary Incontinence Clinical Trial

— NG  

Official title:

Injectable Bulking Agent Needle Guide

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00763711
• Other study ID #: P1006
• Status: Terminated
• Phase: Phase 1
• First received: September 29, 2008
• Last updated: January 9, 2012
• Start date: June 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2012
• Source: Carbon Medical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intrinsic Sphincter Deficiency
• Urinary Incontinence

Intervention

Device:
• Needle Guided Periurethral Injection
Bulking Agent injection using a needle guide

Locations

Country	Name	City	State
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Advanced Urogynecology	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Carbon Medical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the consistency of the location of the injection site and resulting location of bulking effect		at procedure	No
Primary	Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide.		1 week	Yes
Secondary	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.		at procedure	No

External Links

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