Injectable Bulking Agent Needle Guide

NCT ID: NCT00763711

Last Updated: 2012-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Incontinence Intrinsic Sphincter Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Injection with Needle Guide

Group Type EXPERIMENTAL

Needle Guided Periurethral Injection

Intervention Type DEVICE

Bulking Agent injection using a needle guide

Interventions

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Needle Guided Periurethral Injection

Bulking Agent injection using a needle guide

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Carbon Medical Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean Klein

Role: STUDY_DIRECTOR

Carbon Medical Technologies

Locations

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Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

Advanced Urogynecology

West Chester, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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P1006

Identifier Type: -

Identifier Source: org_study_id

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