Nerve Access Tool Study

Not Applicable

Withdrawn

• Conditions: Cystocele
• Interventions: Device: Facilitate nerve stimulation lead placement with the nerve access tool

• Registration Number: NCT00942474
• Lead Sponsor: MedtronicNeuro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-20
• Study First Submitted QC: 2009-07-20
• Study First Posted: 2009-07-21
• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research Arm	Facilitate nerve stimulation lead placement with the nerve access tool	Facilitate nerve stimulation lead placement with the nerve access tool

Primary Outcome Measures

Name	Time	Method
Electromyography Response	Implant