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Clinical Trials/NCT00942474
NCT00942474
Withdrawn
N/A

A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool

MedtronicNeuro0 sitesOctober 2009
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ConditionsCystocele

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cystocele
Sponsor
MedtronicNeuro
Primary Endpoint
Electromyography Response
Status
Withdrawn
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
March 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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