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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00942474
First received: July 20, 2009
Last updated: February 18, 2014
Last verified: February 2014
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00942474     History of Changes
Other Study ID Numbers: #1632
Study First Received: July 20, 2009
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014