Nerve Access Tool Study

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.

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Detailed Description

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Conditions

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Cystocele

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Research Arm

Facilitate nerve stimulation lead placement with the nerve access tool

Group Type EXPERIMENTAL

Facilitate nerve stimulation lead placement with the nerve access tool

Intervention Type DEVICE

Interventions

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Facilitate nerve stimulation lead placement with the nerve access tool

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is equal to or greater than 18 years of age
* Subject has a diagnosis of cystocele with planned surgical repair
* Subject has no known deficit of the nerve
* Subject is willing and able to provide written informed consent and HIPAA authorization to participate by signing the Informed Consent/Health Insurance Portability and Accountability Act Form after a full explanation of the nature and purpose of this study
* Subject is willing and able to comply with the study protocol

Exclusion Criteria

* Subject has known neurological abnormalities of the nerve
* Subject has a known allergy to the tool or neurostimulation lead components
* Subject is pregnant or lactating

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No