Injectable Bulking Agent Needle Guide (NG)
This study has been terminated.
Sponsor:
Carbon Medical Technologies
Information provided by (Responsible Party):
Carbon Medical Technologies
ClinicalTrials.gov Identifier:
NCT00763711
First received: September 29, 2008
Last updated: January 9, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Incontinence Intrinsic Sphincter Deficiency |
Device: Needle Guided Periurethral Injection |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Injectable Bulking Agent Needle Guide |
Resource links provided by NLM:
Further study details as provided by Carbon Medical Technologies:
Primary Outcome Measures:
- to evaluate the consistency of the location of the injection site and resulting location of bulking effect [ Time Frame: at procedure ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
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. [ Time Frame: at procedure ] [ Designated as safety issue: No ]
| Enrollment: | 17 |
| Study Start Date: | June 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Injection with Needle Guide |
Device: Needle Guided Periurethral Injection
Bulking Agent injection using a needle guide
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763711
Locations
| United States, Florida | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Ohio | |
| Advanced Urogynecology | |
| West Chester, Ohio, United States, 45069 | |
Sponsors and Collaborators
Carbon Medical Technologies
Investigators
| Study Director: | Dean Klein | Carbon Medical Technologies |
More Information
Additional Information:
No publications provided
| Responsible Party: | Carbon Medical Technologies |
| ClinicalTrials.gov Identifier: | NCT00763711 History of Changes |
| Other Study ID Numbers: | P1006 |
| Study First Received: | September 29, 2008 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Carbon Medical Technologies:
|
Urinary Incontinence ISD |
Additional relevant MeSH terms:
|
Urinary Incontinence Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013