Nerve Access Tool Study

February 18, 2014 updated by: MedtronicNeuro

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

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

Study Overview

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Research Arm
Facilitate nerve stimulation lead placement with the nerve access tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Electromyography Response
Time Frame: Implant
Implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 20, 2009

First Submitted That Met QC Criteria

July 20, 2009

First Posted (Estimate)

July 21, 2009

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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