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Injectable Bulking Agent Needle Guide (NG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763711
Recruitment Status : Terminated
First Posted : October 1, 2008
Last Update Posted : January 10, 2012
Sponsor:
Information provided by (Responsible Party):
Carbon Medical Technologies

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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Intrinsic Sphincter Deficiency Device: Needle Guided Periurethral Injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Injectable Bulking Agent Needle Guide
Study Start Date : June 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Injection with Needle Guide Device: Needle Guided Periurethral Injection
Bulking Agent injection using a needle guide




Primary Outcome Measures :
  1. to evaluate the consistency of the location of the injection site and resulting location of bulking effect [ Time Frame: at procedure ]
  2. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763711


Locations
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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
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Study Director: Dean Klein Carbon Medical Technologies
Additional Information:
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Responsible Party: Carbon Medical Technologies
ClinicalTrials.gov Identifier: NCT00763711    
Other Study ID Numbers: P1006
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012
Keywords provided by Carbon Medical Technologies:
Urinary Incontinence
ISD
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders