Status:

WITHDRAWN

Nerve Access Tool Study

Lead Sponsor:

MedtronicNeuro

Conditions:

Cystocele

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00942474

Start Date

October 1 2009

End Date

March 1 2010

Last Update

February 19 2014

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Nerve Access Tool Study | DecenTrialz