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Nerve Access Tool Study

This study has been withdrawn prior to enrollment.
(Medtronic made a business decision to discontinue the study and withdraw the IDE.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942474
First Posted: July 21, 2009
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedtronicNeuro
  Purpose
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.

Condition Intervention
Cystocele Device: Facilitate nerve stimulation lead placement with the nerve access tool

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Electromyography Response [ Time Frame: Implant ]

Enrollment: 0
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Research Arm
Facilitate nerve stimulation lead placement with the nerve access tool
Device: Facilitate nerve stimulation lead placement with the nerve access tool

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00942474     History of Changes
Other Study ID Numbers: #1632
First Submitted: July 20, 2009
First Posted: July 21, 2009
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by MedtronicNeuro:
The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement

Additional relevant MeSH terms:
Cystocele
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical