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Nerve Access Tool Study

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ClinicalTrials.gov Identifier: NCT00942474
Recruitment Status : Withdrawn (Medtronic made a business decision to discontinue the study and withdraw the IDE.)
First Posted : July 21, 2009
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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

Condition or disease Intervention/treatment
Cystocele Device: Facilitate nerve stimulation lead placement with the nerve access tool

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: Research Arm
Facilitate nerve stimulation lead placement with the nerve access tool
Device: Facilitate nerve stimulation lead placement with the nerve access tool



Primary Outcome Measures :
  1. Electromyography Response [ Time Frame: Implant ]


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

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00942474     History of Changes
Other Study ID Numbers: #1632
First Posted: July 21, 2009    Key Record Dates
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