Nerve Access Tool Study

MedtronicNeuro

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Conditions

Cystocele

Interventions

Facilitate nerve stimulation lead placement with the nerve access toolDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Electromyography Response

Time frame: Implant

Data from ClinicalTrials.gov

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